Showing posts with label Journal Club. Show all posts
Showing posts with label Journal Club. Show all posts

Friday, June 18, 2010

Opioid Dependence

Attached a very interesting article supporting the fact that office based treatment of opioid dependence can decrease illegal activity and incarceration.
Yours
Bernd

Family Practice News

Volume 40, Issue 10, Page 31 (1 June 2010)


Opioid-Dependent Patients Respond to Therapy

DIANA MAHONEY

Article Outline


Major Finding: Office-based buprenorphine/naloxone treatment was associated with a statistically significant decrease in participants reporting illegal activity, from 19% to 2%, and in interacting with the legal system, from 16% to 1%.

Data Source: A secondary analysis of data from a randomized clinical trial of 166 opioid-addicted individuals treated with buprenorphine/naloxone in a primary care clinic.

Disclosures: Dr. Fiellin reported no relevant financial conflicts of interest.

MINNEAPOLIS — Opioid-dependent patients with a history of incarceration do well with office-based buprenorphine/naloxone therapy and have fewer interactions over time with the legal and criminal justice systems, according to a data analysis of a previous randomized, controlled trial.

“Our findings should offer some reassurance for community health care providers about initiating buprenorphine/naloxone treatment in the office setting,” Dr. David Fiellin reported. Office-based buprenorphine/naloxone treatment also can be an avenue for addressing other negative health consequences of chronic addiction, including referral for hepatitis C treatment, when indicated, as well as vocational and mental health programs.

Dr. Fiellin, along with lead investigator Dr. Emily Wang and colleagues at Yale University, New Haven, Conn., performed a secondary data analysis of a previous trial of three levels of psychosocial counseling and medication dispensing in conjunction with buprenorphine/naloxone maintenance treatment in a primary care clinic (N. Engl. J. Med. 2006;355:365-74).

The investigators compared demographics, clinical characteristics, and treatment outcomes for 166 adults receiving primary care–based buprenorphine/naloxone treatment, stratifying by history of incarceration as determined by the legal domain of the Addiction Severity Index.

Of the 166 patients, 52 had previously been incarcerated, Dr. Fiellin reported. Former inmates were more likely than other patients to be older, male, an ethnic minority, and unemployed. Also, they were more likely to have long histories of opioid dependence, have received methadone treatment, and have hepatitis C infection. The mean dose of buprenorphine/naloxone (Suboxone) was 17.9 mg and 18.0 mg for the previously incarcerated and never incarcerated patients, respectively, he said.

Among the previously incarcerated patients, the mean consecutive weeks of opioid abstinence was 6.2 based on opioid-negative urine samples. For other patients, it was 5.9 weeks. Mean treatment duration was 17.9 weeks and 17.6 weeks. The percentage of previously incarcerated patients completing treatment was 38%; for other patients, it was 46%.

Among patients who remained in treatment, a subsequent longitudinal analysis of self-reported illegal activity and interactions with the legal and criminal justice systems, conducted at 4-week intervals, showed “office-based buprenorphine/naloxone treatment was associated with a statistically significant decrease in participants reporting illegal activity, from 19% to 2%, and in interactions with the legal system, from 16% to 1%,” Dr. Fiellin said.

About “25% of all of those dependent on heroin pass through the criminal justice system each year,” Dr. Fiellin said. Correctional facilities provide an obvious opportunity to engage opioid-dependent individuals with treatment. “Unfortunately, less than 0.5% of all opioid-dependent individuals receive treatment while incarcerated, and as such they are more likely to connect with services in office-based programs upon release,” he said.

From the Annual Meeting of the Society of General Internal Medicine

Saturday, March 14, 2009

Opioid Dependence Treatment

Attached an interesting article. Check out the Journal for a full text.
Bernd

Journal of Addiction Medicine:Volume 2(4)December 2008pp 194-201
Prediction of Abstinence in Opioid-Dependent Patients
[Original Article]

Dijkstra, Boukje A. G. MSc*†; De Jong, Cor A. J. MD, PhD*†§; Krabbe, Paul F. M. PhD‡; van der Staak, Cees P. F. PhD§

From the *Novadic-Kentron, Network for Addiction Treatment Services, Vught, The Netherlands; †Nijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Radboud University Nijmegen, Nijmegen, The Netherlands; ‡Department of Epidemiology, Biostatistics and Health Technology Assessment, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands; and §Department of Clinical Psychology, Radboud University Nijmegen, Nijmegen, The Netherlands.

Received for publication May 20, 2008; accepted Aug 13, 2008.

Send correspondence and reprint requests to Boukje A. G. Dijkstra, NISPA, P.O. Box 9104, 6500 HE, Nijmegen, The Netherlands. e-mail: boukje.dijkstra@novadic-kentron.nl.
Abstract

Objectives: Opioid detoxification with subsequent naltrexone is found to be an effective method as the first step in an abstinence-oriented approach. The aim of this study is to investigate the predictive value of variables for abstinence in opioid-dependent patients.

Methods: Opioid-dependent patients were followed up to 1 month after detoxification. Predictor variables were assessed at baseline, during detoxification, and at discharge. Primary outcome was abstinence assessed by analyzing urine samples and self-reports. Logistic regression was used to identify predictors of abstinence.

Results: Of 272 participants, 211 could be rated as abstinent (59.2%) or nonabstinent (40.8%) at 1 month follow-up. Significant baseline predictors were severity score of justice/police (ASI) and physical quality of life (SF-36); discharge predictors were general quality of health (SF-36) and sleeping problems (SCL-90); change in sleeping problems (SCL-90) during detoxification was also a predictor. The explained variance of these predictors was very low and clinical significance was limited.

Conclusions: Considering the results it seems not possible to predict who will be abstinent or not 1 month after detoxification. Because rapid detoxification is found to be an effective detoxification method in selected patients, it seems warranted to recommend that patients with similar characteristics (ie, patients motivated for an abstinence-based treatment and low non-drug-related severity scores on the ASI) should be regarded as eligible for rapid detoxification.
© 2008 American Society of Addiction Medicine

Tuesday, February 17, 2009

Pain Treatment Guidelines

Dear Friends and Colleagues:
Attached a very interesting article which I received from two of our FSAM board members.
Thanks John and Michelle.
Looking forward to your comments.
Yours
Bernd
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Two professional societies released guidelines last week on opioid therapy to treat chronic, noncancer pain.

The American Pain Society and the American Academy of Pain Medicine convened a multidisciplinary panel of 21 experts to review evidence and compose 25 recommendations. The recommendations, published in the February Journal of Pain, advise providers to:

=Do a history, physical exam and appropriate testing—including a risk assessment of substance abuse—before starting a patient on chronic opioid therapy (COT);
=Consider a COT trial for patients whose pain is moderate or severe and for whom it has an adverse impact on function or quality of life;
=Reassess patients on COT periodically, with monitoring to include documenting pain and functioning levels, adherence, and presence of adverse events;
=Use COT on patients with a history of drug abuse or psychiatric issues only if they can be monitored more frequently and strictly;
=Do periodic urine drug screens on patients at high risk or who engaged in drug-related behavior in the past, and possibly on patients who aren't high-risk, too; and
=Evaluate health status, adherence and side effects on an ongoing basis in patients on high doses of COT, and consider more follow-up visits.

On a related note, FDA last week sent letters to opioid manufacturers asking them to develop plans to reduce the misuse of their drugs, the Feb. 9 Washington Post reported. The plans, which are meant to help reduce the rising incidence of overdose and abuse, might include enhanced warnings on labels or restricting the kinds of patients who can use the drugs, the Post said. A list of affected drugs, most of which are high dose and/or extended release, is online.

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Article Abstract
The Journal of Pain, Volume 10, Issue 2, Pages 113-130.e22 (February 2009)

Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain

Roger Chou1, Gilbert J. Fanciullo2, Perry G. Fine3, Jeremy A. Adler4, Jane C. Ballantyne5, Pamela Davies6, Marilee I. Donovan7, David A. Fishbain8, Kathy M. Foley9, Jeffrey Fudin10, Aaron M. Gilson11, Alexander Kelter12, Alexander Mauskop13, Patrick G. O'Connor14, Steven D. Passik15, Gavril W. Pasternak16, Russell K. Portenoy17, Ben A. Rich18, Richard G. Roberts19, Knox H. Todd20, Christine Miaskowski21, American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel
Abstract
Use of chronic opioid therapy for chronic noncancer pain has increased substantially. The American Pain Society and the American Academy of Pain Medicine commissioned a systematic review of the evidence on chronic opioid therapy for chronic noncancer pain and convened a multidisciplinary expert panel to review the evidence and formulate recommendations. Although evidence is limited, the expert panel concluded that chronic opioid therapy can be an effective therapy for carefully selected and monitored patients with chronic noncancer pain. However, opioids are also associated with potentially serious harms, including opioid-related adverse effects and outcomes related to the abuse potential of opioids. The recommendations presented in this document provide guidance on patient selection and risk stratification; informed consent and opioid management plans; initiation and titration of chronic opioid therapy; use of methadone; monitoring of patients on chronic opioid therapy; dose escalations, high-dose opioid therapy, opioid rotation, and indications for discontinuation of therapy; prevention and management of opioid-related adverse effects; driving and work safety; identifying a medical home and when to obtain consultation; management of breakthrough pain; chronic opioid therapy in pregnancy; and opioid-related polices.

Perspective

Safe and effective chronic opioid therapy for chronic noncancer pain requires clinical skills and knowledge in both the principles of opioid prescribing and on the assessment and management of risks associated with opioid abuse, addiction, and diversion. Although evidence is limited in many areas related to use of opioids for chronic noncancer pain, this guideline provides recommendations developed by a multidisciplinary expert panel after a systematic review of the evidence.

Link to full article: http://www.jpain.org/article/PIIS1526590008008316/fulltext

Monday, February 16, 2009

Interesting articles

Dear Friends and Colleagues:
By reviewing several journals I found the attached articles which may help you to manage patients in your office:

1) Realistic Approaches to Counseling in the Office Setting,
H. RUSSELL SEARIGHT, PhD, MPH, Department of Psychology, Lake Superior State University, Sault Sainte Marie, Michigan
Although it is often unrecognized, family physicians provide a significant amount of mental health care in the United States. Time is one of the major obstacles to providing counseling in primary care. Counseling approaches developed specifically for ambulatory patients and traditional psychotherapies modified for primary care are efficient first-line treatments. For some clinical conditions, providing individualized feedback alone leads to improvement. The five A's (ask, advise, assess, assist, arrange) and FRAMES (feedback about personal risk, responsibility of patient, advice to change, menu of strategies, empathetic style, promote self-efficacy) techniques are stepwise protocols that are effective for smoking cessation and reducing excessive alcohol consumption. These models can be adapted to address other problems, such as treatment nonadherence. Although both approaches are helpful to patients who are ready to change, they are less likely to be successful in patients who are ambivalent or who have broader psychosocial problems. For patients who are less committed to changing health risk behavior or increasing healthy behavior, the stages-of-change approach and motivational interviewing address barriers. Patients with psychiatric conditions and acute psychosocial stressors will likely respond to problem-solving therapy or the BATHE (background, affect, troubles, handling, empathy) technique. Although brief primary care counseling has been effective, patients who do not fully respond to the initial intervention should receive multimodal therapy or be referred to a mental health professional. (Am Fam Physician. 2009;79(4):277-284. Copyright © 2009 American Academy of Family Physicians.)
http://www.aafp.org/afp/20090215/277.html

2) Reducing Tobacco Use in Adolescents
IRENE M. ROSEN, LTC, MC, USA, Madigan Army Medical Center, Fort Lewis, Washington
DOUGLAS M. MAURER, MAJ, MC, USA, Carl R. Darnall Army Medical Center, Fort Hood, Texas
After steadily decreasing since the late 1990s, adolescent smoking rates have stabilized at levels well above national goals. Experts recommend screening for tobacco use and exposure at every patient visit, although evidence of improved outcomes in adolescents is lacking. Counseling should be provided using the 5-A method (ask, advise, assess, assist, and arrange). All smokers should be offered smoking cessation assistance, including counseling, nicotine replacement therapy, bupropion therapy, or combination therapy. Pharmacotherapy of any kind doubles the likelihood of successful smoking cessation in adults; however, nicotine replacement therapy is the only pharmacologic intervention that has been extensively studied in children. Community interventions such as smoking bans and educational programs have been effective at reducing smoking rates in children and adolescents. Antismoking advertising and tobacco sales taxes also help deter new smokers and motivate current smokers to attempt to quit. (Am Fam Physician. 2008;77(4):483-490, 491-492. Copyright © 2008 American Academy of Family Physicians.)
http://www.aafp.org/afp/20080215/483.html

3) Adolescent Substance Use and Abuse: Recognition and Management
KIM S. GRISWOLD, MD, MPH; HELEN ARONOFF, MD, MAT; JOAN B. KERNAN, BS; and LINDA S. KAHN, PhD State University of New York at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York
Substance abuse in adolescents is undertreated in the United States. Family physicians are well positioned to recognize substance use in their patients and to take steps to address the issue before use escalates. Comorbid mental disorders among adolescents with substance abuse include depression, anxiety, conduct disorder, and attention-deficit/hyperactivity disorder. Office-, home-, and school-based drug testing is not routinely recommended. Screening tools for adolescent substance abuse include the CRAFFT questionnaire. Family therapy is crucial in the management of adolescent substance use disorders. Although family physicians may be able to treat adolescents with substance use disorders in the office setting, it is often necessary and prudent to refer patients to one or more appropriate consultants who specialize specifically in substance use disorders, psychology, or psychiatry. Treatment options include anticipatory guidance, brief therapeutic counseling, school-based drug-counseling programs, outpatient substance abuse clinics, day treatment programs, and inpatient and residential programs. Working within community and family contexts, family physicians can activate and oversee the system of professionals and treatment components necessary for optimal management of substance misuse in adolescents. (Am Fam Physician. 2008;77(3):331-336. Copyright © 2008 American Academy of Family Physicians.)
http://www.aafp.org/afp/20080201/331.html

I look forward to your feedback.
Yours
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine

Saturday, February 7, 2009

Addiction Treatment and the Criminal Justice System

Attached a very interesting an timely article summarizing relevant neuroscientific findings and evidence-based principles of addiction treatment that, if implemented in the criminal justice system, could help improve public heath and reduce criminal behavior.
The basic premise of the article is that not treating a drug-abusing offender is a missed opportunity to simultaneously improve both public health and safety. Integrating treatment into the criminal justice system would provide treatment to individuals who otherwise would not receive it, improving their medical outcomes and decreasing their rates of reincarceration.
Research over the last 2 decades has consistently reported the beneficial effects of treatment for the drug abuser in the criminal justice system.These interventions include therapeutic alternatives to incarceration, treatment merged with judicial oversight in drug courts, prison- and jail-based treatments, and reentry programs intended to help offenders transition from incarceration back into the community.Through monitoring, supervision, and threat of legal sanctions, the justice system can provide leverage to encourage drug abusers to enter and remain in treatment.
Effective interventions depend on a coordinated response between criminal justice agencies, drug abuse treatment providers, mental health and physical health care organizations, and social service agencies. Each type of criminal justice agency (eg, jail, drug court, probation, prison) has its own role in sanctioning and supervision and lends itself to specific intervention opportunities.
Effective integration of drug treatment interventions into criminal justice settings requires matching the intervention to the organization. For example, since jail stays are usually brief, the interventions best suited to jails may be screening for drug and alcohol abuse, other mental illnesses, and medical conditions (eg, HIV, hepatitis B or C), with referral to community-based treatment providers. Implementing these principles throughout the criminal justice and drug abuse treatment systems also requires that these systems work together to address the addicted individual's drug use, comorbid mental disorders and medical conditions, if present, and criminal behavior. Treatment professionals should understand the criminal justice process and the supervision requirements of their patients. In addition to addressing drug use behaviors, treatment outcomes improve when antisocial and criminal behaviors are targets of clinical intervention.Criminal justice professionals must develop an understanding of addiction—signs and symptoms, treatment, and relapse—and their role in facilitating recovery.
The challenge of delivering treatment in a criminal setting requires the cooperation and coordination of 2 disparate cultures: the criminal justice system organized to punish the offender and protect society and the drug abuse treatment systems organized to help the addicted individual. Addressing addiction as a disease does not remove the responsibility of the individual, which is the argument frequently used to resist recognizing and treating addiction as an illness. Rather it highlights the personal responsibility of the addicted person to seek and adhere to drug treatment and that of society to ensure that such treatment is available and based on scientific evidence. Only a small percentage of those requiring treatment for drug addiction seek help voluntarily; in light of this, the criminal justice system provides a unique opportunity to intervene and disrupt the cycle of drug use and crime in a cost-effective manner.

For those interested I can e-mail a PDF version of the complete article.
See you soon in Tampa for our Annual Scientific Conference

Yours
Bernd Wollschlaeger,MD,FAAFp,FASAM
President,Florida Society of Addiction Medicine

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Treating Drug Abuse and Addiction in the Criminal Justice System: Improving Public Health and Safety

Redonna K. Chandler, PhD; Bennett W. Fletcher, PhD; Nora D. Volkow, MD

JAMA. 2009;301(2):183-190.

ABSTRACT


Despite increasing evidence that addiction is a treatable disease of the brain, most individuals do not receive treatment. Involvement in the criminal justice system often results from illegal drug-seeking behavior and participation in illegal activities that reflect, in part, disrupted behavior ensuing from brain changes triggered by repeated drug use. Treating drug-involved offenders provides a unique opportunity to decrease substance abuse and reduce associated criminal behavior. Emerging neuroscience has the potential to transform traditional sanction-oriented public safety approaches by providing new therapeutic strategies against addiction that could be used in the criminal justice system. We summarize relevant neuroscientific findings and evidence-based principles of addiction treatment that, if implemented in the criminal justice system, could help improve public heath and reduce criminal behavior.



INTRODUCTION




The past 20 years have seen significant increases in the numbers of individuals incarcerated or under other forms of criminal justice supervision in the United States. These numbers are staggering—approximately 7.1 million adults in the United States are under some form of criminal justice supervision.1 The large increase in the criminal justice population reflects in part tougher laws and penalties for drug offenses.2 An estimated one-half of all prisoners (including some sentenced for other than drug offenses) meet the criteria for diagnosis of drug abuse or dependence (Table 1).3-4


During the past 20 years, fundamental advances in the neurobiology of addiction have been made. Molecular and imaging studies have revealed addiction as a brain disorder with a strong genetic component, and this has galvanized research on new pharmacological treatments. However, a large disconnect remains between addiction research and the treatment of addiction in general, particularly within the criminal justice system. This is evidenced in that most prisoners (80%-85%) who could benefit from drug abuse treatment do not receive it.3-4 In addition, drug-using offenders are at high risk for infectious diseases such as human immunodeficiency virus (HIV) and hepatitis C5 and frequently have comorbid psychiatric disorders,6-7 which further highlights the dire treatment needs of this population.

Not treating a drug-abusing offender is a missed opportunity to simultaneously improve both public health and safety. Integrating treatment into the criminal justice system would provide treatment to individuals who otherwise would not receive it, improving their medical outcomes and decreasing their rates of reincarceration.8


Recidivism in the Drug-Abusing Offender



The inadequacy of incarceration by itself in addressing drug abuse or addiction is evident in the statistics. A review of recidivism in 15 states found that one-quarter of individuals released returned to prison within 3 years for technical violations that included, among other things, testing positive for drug use.9 Illicit drugs are used in jails and prisons despite their highly structured, controlled environments,10 but even enforced abstinence can mislead criminal justice professionals as well as addicted persons to underestimate the vulnerability to relapse postincarceration. On release from prison or jail, addicted persons will experience challenges to their sobriety through multiple stressors that increase their risk of relapsing to drug use. These include the stigma associated with being labeled an ex-offender, the need for housing and legitimate employment, stresses in reunifying with family, and multiple requirements for criminal justice supervision.11-12

Returning to neighborhoods associated with preincarceration drug use places the addicted individual in an environment rich in drug cues. As discussed below, these conditioned cues automatically activate the reward/motivational neurocircuitry and can trigger an intense desire to consume drugs (craving).13 The molecular and neurobiological adaptations resulting from chronic drug use persist for months after drug discontinuation,14 and evidence exists that compulsive seeking of drugs when addicted individuals are reexposed to drug cues progressively increases after drug withdrawal.15 This could explain why many drug-addicted individuals rapidly return to drug use following long periods of abstinence during incarceration and highlights the need for ongoing treatment following release.


Drug Abuse Treatment Effectiveness in the Criminal Justice System




Research over the last 2 decades has consistently reported the beneficial effects of treatment for the drug abuser in the criminal justice system.16-17 These interventions include therapeutic alternatives to incarceration, treatment merged with judicial oversight in drug courts, prison- and jail-based treatments, and reentry programs intended to help offenders transition from incarceration back into the community.8, 18 Through monitoring, supervision, and threat of legal sanctions, the justice system can provide leverage to encourage drug abusers to enter and remain in treatment.

Behavioral treatments are the most commonly used interventions for addressing substance use disorders. Evidence-based behavioral interventions include cognitive therapies that teach coping and decision-making skills, contingency management therapies that reinforce behavioral changes associated with abstinence, and motivational therapies that enhance the motivation to participate in treatment and in non–drug-related activities.19-20 Many residential treatment programs rely on the creation of a "therapeutic community" based on a social learning model.21 Medications such as methadone, buprenorphine, and naltrexone are beneficial for the treatment of heroin addiction and naltrexone and topiramate for the treatment of alcoholism.22-24 Self-help programs such as Alcoholics Anonymous or SMART Recovery can be valuable adjuncts to formal drug treatment.25

Research has consistently shown that community-based drug abuse treatment can reduce drug use and drug-related criminal behavior.26 A meta-analysis of 78 comparison-group community-based drug treatment studies found treatment to be up to 1.8 times better in reducing drug use than the usual alternatives.20 In a meta-analysis of 66 incarceration-based treatment evaluations, therapeutic community and counseling approaches were respectively 1.4 and 1.5 times more likely to reduce reoffending.27 Drug courts combine judicial supervision with drug treatment as an alternative to incarceration; their graduates have rearrest rates about half those of matched comparison samples and much lower than those of drug court dropouts.28 Individuals who participated in prison-based treatment followed by a community-based program postincarceration were 7 times more likely to be drug free and 3 times less likely to be arrested for criminal behavior than those not receiving treatment.29-30

The benefits of medications for drug treatment were shown in a recent randomized trial in which heroin-dependent inmates began methadone treatment in prison prior to release and continued in the community postrelease. At 1-, 3-, and 6-month follow-up, patients who received methadone plus counseling were significantly less likely to use heroin or engage in criminal activity than those who received only counseling.31-33 The potential exists for immediate adoption of methadone maintenance for incarcerated persons with opioid addictions, but most prison systems have not been receptive to this approach.34

Economic analyses highlight the cost-effectiveness of treating drug-involved offenders.35 On average, incarceration in the United States costs approximately $22 000 per month,36 and there is little evidence that this strategy reduces drug use or drug-related reincarceration rates for nonviolent drug offenders. By contrast, the average cost of methadone is $4000 per month,37 and treatment with methadone has demonstrated effectiveness in reducing drug use and criminal activity following release.31 Alternatives to incarceration can also defray job productivity losses and the separation from family and social support systems.

The cost of integrating volunteer-led self-help organizations such as Alcoholics Anonymous and Narcotics Anonymous into criminal justice settings is nominal and could provide support to the recovery efforts of addicted persons in the criminal justice system. One dollar spent on drug courts is estimated to save approximately $4 in avoided costs of incarceration and health care,38 and prison-based treatment saves between $2 to $6.39 These economic benefits in part reflect reductions in criminal behavior.40-41


Access to Treatment



Drug education—not drug treatment—is the most common service provided to prisoners with drug abuse or addiction problems.4, 42 More than one-quarter of state inmates and 1 in 5 federal inmates meeting abuse/dependence criteria participate in self-help groups such as Alcoholics Anonymous while in prison.4 However, though treatment during and after incarceration has been shown to significantly reduce drug use and drug-related crime, less than 20% of inmates with drug abuse or dependence receive formal treatment (Table 1).3-4

In a recent survey of correctional programs and organizations across the United States,42 most correctional agencies reported providing some type of drug abuse treatment services; however, the median percentage of offenders who had access to those services at any given time was low, usually less than 10% (Table 2).42 Even if a correctional institution does provide treatment, the continuity of treatment postincarceration, which is essential to recovery,16 is often lacking when the drug-involved offender transitions from incarceration to community supervision.43 Failure to receive treatment on release increases the risk not only of relapse but also of mortality from drug overdose and other causes.44


Infectious diseases such as HIV and hepatitis C are associated with illicit drug use and occur at higher rates in correctional populations than in the general population,5 but treatment for these conditions appears to fall short of need.45-46 It is feasible to implement screening and treatment in correctional settings for HIV47-48 and hepatitis C.49-50 Continuity of treatment for released offenders with infectious disease is crucial not only for the individual's health51-52 but also for the health of the community.45, 53

There are many barriers to treatment for the drug-involved offender, including lack of the resources, infrastructure, and treatment staff (including physicians knowledgeable about addiction medicine) required to meet the drug treatment needs of individuals under their supervision. Addiction remains a stigmatized disease not often regarded by the criminal justice system as a medical condition; as a consequence, treatment is not constitutionally guaranteed as is the treatment of other medical conditions.


Neurobiology of Addiction





Addiction is a chronic brain disease for which genetic factors are believed to contribute 40% to 60% of the vulnerability.54 Repeated drug exposure in individuals who are vulnerable (because of genetics, or developmental or environmental factors) trigger neuroadaptations in the brain that result in the compulsive drug use and loss of control over drug-related behaviors that characterizes addiction. Molecular and neuroimaging studies have helped illuminate how genes may affect vulnerability to addiction and how repeated use of addictive drugs causes long-lasting disruptions to the structure and function of the brain.55 Among the genes identified to contribute to the vulnerability for addiction are those that participate in the neuroplastic changes associated with learning.56 Imaging studies have identified multiple brain circuits that are disrupted in addicted persons57; these include circuits involved in reward and motivation, learning and memory, cognitive control, mood, and interoception (awareness of physiological body signals) (Figure). Disruption of these circuits impairs the addicted person's ability to inhibit intentional actions or to control strong emotions and desires and also increases the likelihood that the individual will have difficulties making adaptive decisions.60-61

Circuits work together and change with experience. Each is linked to an important concept: reward (saliency), motivation (drive), memory (learning associations), inhibitory control (conflict resolution), mood (well-being),58 and interoception (internal awareness).59 Size of circuit ovals indicates influence in determining behavioral outcomes. Thicker line weights indicate greater influence on regulation of the circuit. A, In a nonaddicted person the decision to consume a drug (same process pertains for natural rewards) is a function of the balance between the expected pleasure (based on past experience or memory), alternative stimuli (this includes internal states such as mood and interoception but also alternative external rewards), and potential negative outcomes that oppose the motivation to take the drug (inhibitory control exerted by prefrontal cortex) and stop the drug use. B, During addiction, the enhanced value of the drug in the reward, motivation, and memory circuits overcomes the inhibitory control exerted by the prefrontal cortex, thereby favoring a positive feedback loop initiated by the consumption of the drug and perpetuated by enhanced activation of the motivation/drive and memory circuits. Decreased sensitivity to rewards also raises the hedonic threshold, disrupting mood and increasing the saliency values of drugs and behaviors temporarily associated with relief from the dysphoria. Learning and conditioning result in an enhanced interoceptive awareness of discomfort and the associated desire for the drug (craving). Absence of lines from inhibitory control circuit to reward and motivation circuits indicates loss of regulation.




Addiction also decreases sensitivity in the reward and the motivational circuits, which modulate response to positive as well as negative reinforcers. Practically, this suggests that an addicted individual may experience less motivation to pursue activities likely to result in beneficial outcomes and to avoid those that could result in punishment. One can also predict that dysfunction in this neurocircuitry would reduce an addicted person's motivation to abstain from drug use because alternative reinforcers (natural stimuli) are comparatively weaker and negative consequences (eg, incarceration) are less salient.62

In parallel, the repeated use of drugs leads to the formation of new linked memories that condition the addicted individual to expect pleasurable responses—not only when exposed to a drug but also when exposed to stimuli associated with the drug. These stimuli trigger automatic responses that frequently drive relapse, even in individuals motivated to stop taking drugs.63 The enhanced sensitivity to drugs as rewards and the conditioning to associated drug cues increase the interoceptive awareness of discomfort (anxiety and tension) that occurs when the individual is exposed to drug cues and increase the desire to consume the drug.64 Additionally, repeated drug use also affects brain regions implicated in mood and anxiety, which could explain the high rate of addiction comorbid with dysphoria, depression, or both and the vulnerability of the addicted person to relapse when exposed to social stressors.65-66

Impairment of the neural substrates affected by addiction—particularly those concerned with behavioral inhibition, control of emotions and desires, and decision-making—increase the likelihood that addicted individuals will make choices that appear impulsive.67-68 This idea is supported by research in the emerging area of behavioral economics, which has found that addicted individuals differ from those who do not use drugs in how they make decisions. Addicted individuals tend to have higher levels of temporal discounting than those who do not use drugs; ie, they tend to choose immediate, smaller rewards over future, larger rewards.69 High temporal discounting is also associated with impulsivity—the inability to delay immediate gratification and to recognize the potential for negative consequences.70

Many of the neurobiological changes associated with repeated drug use persist for long periods after drug discontinuation.71 This helps explain why addicted individuals who have ceased drug use are at high risk of relapse and provides neurobiological support for the recognition of addiction as a chronic relapsing disease.72

What are the implications of neuroscience research for how society and clinicians might regard the addicted offender? There are at least 3 implications for how this emerging knowledge about the neurologic basis of addictive behavior is important.

First, of most importance, neuroscience's uncovering of new molecular targets implicated in the responses to drugs and of new knowledge on the function of the human brain provides new targets for medication development and behavioral interventions in addiction. Although many of the neurobiological changes associated with repeated drug use persist for long periods after drug discontinuation,71 research suggests that the impaired brain can regain some of the functions damaged by use of illicit drugs over time.73

Second, neuroscience establishes a biological framework for understanding aspects of addictive behavior that otherwise seem to defy rational explanation. In the absence of known biological determinants, these behaviors often have been attributed to "moral weakness."74 Identifying the neurologic factors underlying addictive behavior can place these moral arguments into a more reasoned context. Addiction does not absolve one of responsibility for use of illicit drugs or for criminal behavior, but understanding how addictive drugs affect behavior through brain mechanisms can inform decisions to provide treatment to addicted individuals. For example, mandated treatment may be useful for drug-involved offenders who would otherwise not engage in the treatment process or make progress toward recovery. The persistence of neurologic deficits provides support for the recognition of addiction as a chronic disease and highlights the need for the same continuity of care so important in treatment of other chronic diseases (eg, asthma, hypertension).72 It also suggests that agonist medications such as methadone are important treatments for addiction, even for individuals who have been under enforced abstinence during incarceration.

Third, neuroscience may help addicted individuals to better understand their own addiction. Such individuals may become frustrated when their efforts to control their own drug use are unsuccessful, and even with treatment many become frustrated with what is often a slow and tenuous recovery process. The neurobiology of the brain can help the addicted individual put this disease into a more understandable context and thereby facilitate effective treatment. Little research has been conducted in the field of addiction on whether knowing more about the substance use disorder is useful in helping to sustain recovery, and more research is needed. However, the concept of the "expert patient" who serves as his or her own best health advocate in a recovery management paradigm has been promoted for chronic disorders. As with these other illnesses, addiction must be managed by the individual over time to sustain recovery.

Principles of Drug Abuse Treatment for Offenders

Principles of Drug Abuse Treatment for Criminal Justice Populations,75 published by the National Institute on Drug Abuse, synthesizes research on drug abuse treatment for drug abusers in the criminal justice system. It is intended as a resource for criminal justice professionals and the treatment community working with drug abusers involved with the system. The publication summarizes 20 years of research to provide guidance on evidence-based practices and identifies general principles on how to effectively address the drug abuse problems of populations involved with the criminal justice system (Box).75



Implementing the Principles

Effective interventions depend on a coordinated response between criminal justice agencies, drug abuse treatment providers, mental health and physical health care organizations, and social service agencies. Each type of criminal justice agency (eg, jail, drug court, probation, prison) has its own role in sanctioning and supervision and lends itself to specific intervention opportunities. Table 3 provides a simplified overview of the criminal justice system and identifies the points at which intervention is possible.




Effective integration of drug treatment interventions into criminal justice settings requires matching the intervention to the organization. For example, since jail stays are usually brief, the interventions best suited to jails may be screening for drug and alcohol abuse, other mental illnesses, and medical conditions (eg, HIV, hepatitis B or C), with referral to community-based treatment providers. Implementing these principles throughout the criminal justice and drug abuse treatment systems also requires that these systems work together to address the addicted individual's drug use, comorbid mental disorders and medical conditions, if present, and criminal behavior. Treatment professionals should understand the criminal justice process and the supervision requirements of their patients. In addition to addressing drug use behaviors, treatment outcomes improve when antisocial and criminal behaviors are targets of clinical intervention.76 Criminal justice professionals must develop an understanding of addiction—signs and symptoms, treatment, and relapse—and their role in facilitating recovery.

Substance Abuse Treatment Research in Criminal Justice Settings

Prison environments are inherently coercive,77 and special safeguards have been developed to ensure that prisoners can choose freely whether to participate in biomedical research without fear of consequence. Beyond mere equipoise, clinical trials must be designed so the research is of benefit to the prisoner participant regardless of the assigned study group. Within these constraints, it is important to conduct research to help improve substance abuse treatment and to assist in the successful transition of the substance abuser to the community. To facilitate research in this area, the National Institute on Drug Abuse created the Criminal Justice Drug Abuse Treatment Studies research cooperative,78 a network of correctional agencies linked with treatment research centers and community treatment programs.

Opiate agonist medications used for the treatment of heroin addiction such as methadone and buprenorphine are underused in correctional populations. Naltrexone, an opiate antagonist, was developed to treat heroin addiction but also has been approved for treating alcoholism. Naltrexone is likely to be more acceptable in the criminal justice setting than agonist medications. However, the poor compliance with naltrexone has limited its use in the treatment of heroin addiction. The recent development of a long-lasting depot formulation for naltrexone79-80 obviates this limitation, and a multisite clinical trial (NCT00781898) is currently evaluating its effectiveness in heroin-addicted probationers. Another area of research intended to reduce relapse in addicted offenders is the development of vaccines against cocaine, methamphetamine, or heroin.

Several avenues currently exist for providing drug abuse treatment as an alternative to incarceration. Drug courts were intended to provide a bridge between drug treatment and adjudication; from the first drug court established in Miami in 1989, drug courts have increased in number to nearly 2000 today. States such as Arizona, California, and New York have created treatment alternatives to incarceration for first-time drug offenders, juvenile offenders, and others. Many states are coming under political pressure to reduce the costs associated with incarceration by diverting nonviolent drug offenders to treatment.


Conclusions



Punishment alone is a futile and ineffective response to drug abuse,2 failing as a public safety intervention for offenders whose criminal behavior is directly related to drug use.81 Addiction is a chronic brain disease with a strong genetic component that in most instances requires treatment. The increase in the number of drug-abusing offenders highlights the urgency to institute treatments for populations involved in the criminal justice system. It also provides a unique opportunity to intervene for individuals who would otherwise not seek treatment.

The challenge of delivering treatment in a criminal setting requires the cooperation and coordination of 2 disparate cultures: the criminal justice system organized to punish the offender and protect society and the drug abuse treatment systems organized to help the addicted individual. Addressing addiction as a disease does not remove the responsibility of the individual, which is the argument frequently used to resist recognizing and treating addiction as an illness. Rather it highlights the personal responsibility of the addicted person to seek and adhere to drug treatment and that of society to ensure that such treatment is available and based on scientific evidence. Only a small percentage of those requiring treatment for drug addiction seek help voluntarily; in light of this, the criminal justice system provides a unique opportunity to intervene and disrupt the cycle of drug use and crime in a cost-effective manner.


AUTHOR INFORMATION




Corresponding Author: Nora D. Volkow, MD, National Institute on Drug Abuse, 6001 Executive Blvd, Room 5274, Bethesda, MD 20892 (nvolkow@nida.nih.gov).

Author Contributions: Study concept and design: Chandler, Fletcher, Volkow.

Analysis and interpretation of data: Fletcher.

Drafting of the manuscript: Chandler, Fletcher.

Critical revision of the manuscript for important intellectual content: Chandler, Fletcher, Volkow.

Administrative, technical, or material support: Chandler, Fletcher, Volkow.

Financial Disclosures: None reported.

Funding/Support: This article was written by staff from the National Institute on Drug Abuse and there was no external funding for this work.

Disclaimer: The statements in this article are those of the authors and not necessarily those of the National Institute on Drug Abuse.

Additional Contributions: We thank Faye S. Taxman, PhD, and Matthew Perdoni, MS, both of George Mason University, for data on physical/medical, mental health, and substance use services (Table 2) from the NIDA National Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) National Criminal Justice Treatment Practices Survey. Neither of these individuals received compensation for their contributions.

Author Affiliations: Services Research Branch, National Institute on Drug Abuse (Drs Chandler and Fletcher); and National Institute on Drug Abuse (Dr Volkow), Bethesda, Maryland.


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Alcoholism:Screening and Brief Interventions

Attached several articles highlighting the urgency to diagnose and treat Alcoholism and to implement screening and brief intervention tools.
Clinicians should routinely screen for alcohol disorders, using clinical interviews, questionnaires, blood tests, or a combination of these methods.
Its important to stress that:
"To a large extent the burden attributable to alcohol is preventable and there are proven and effective strategies and interventions to reduce alcohol-related harm. The challenge is getting governments to implement effective alcohol policies in the face of strong industry opposition and widespread public sentiment that alcohol-related harm is a problem confined to a few very heavy drinkers."

I hope that this information can be of value for your clinical practice and I look forward to your feedback.
Yours
Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine
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The Lancet, Volume 373, Issue 9662, Pages 492 - 501, 7 February 2009

Alcohol-use disorders

Dr Marc A Schuckit MD a b
Summary

Alcohol dependence and alcohol abuse or harmful use cause substantial morbidity and mortality. Alcohol-use disorders are associated with depressive episodes, severe anxiety, insomnia, suicide, and abuse of other drugs. Continued heavy alcohol use also shortens the onset of heart disease, stroke, cancers, and liver cirrhosis, by affecting the cardiovascular, gastrointestinal, and immune systems. Heavy drinking can also cause mild anterograde amnesias, temporary cognitive deficits, sleep problems, and peripheral neuropathy; cause gastrointestinal problems; decrease bone density and production of blood cells; and cause fetal alcohol syndrome. Alcohol-use disorders complicate assessment and treatment of other medical and psychiatric problems. Standard criteria for alcohol dependence—the more severe disorder—can be used to reliably identify people for whom drinking causes major physiological consequences and persistent impairment of quality of life and ability to function. Clinicians should routinely screen for alcohol disorders, using clinical interviews, questionnaires, blood tests, or a combination of these methods. Causes include environmental factors and specific genes that affect the risk of alcohol-use disorders, including genes for enzymes that metabolise alcohol, such as alcohol dehydrogenase and aldehyde dehydrogenase; those associated with disinhibition; and those that confer a low sensitivity to alcohol. Treatment can include motivational interviewing to help people to evaluate their situations, brief interventions to facilitate more healthy behaviours, detoxification to address withdrawal symptoms, cognitive-behavioural therapies to avoid relapses, and judicious use of drugs to diminish cravings or
discourage relapses.
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The Lancet, Volume 373, Issue 9662, Page 433, 7 February 2009

Alcohol misuse needs a global response

The Lancet
Around 2 billion people worldwide consume alcoholic beverages and over 76 million people have alcohol-use disorders. In most parts of the world the burden related to alcohol consumption in terms of morbidity, mortality, and disability is substantial. WHO estimates that the harmful use of alcohol causes about 2·3 million premature deaths per year worldwide (3·7% of global mortality) and is responsible for 4·4% of the global burden of disease. Although there are regional and national differences in levels, patterns, and context of drinking, current trends suggest availability and alcohol consumption will continue to rise.
The health effects of alcohol are diverse. The highest alcohol-attributable burdens are neuropsychiatric disorders, which are described in a Seminar by Marc A Schuckit in The Lancet today. Alcohol use increases the risk of cardiovascular diseases and various cancers, as well as injuries and accidents. It increases the transmission of sexually transmitted diseases and HIV infection through association with unsafe sexual practices. The harmful effects of alcohol are associated with many adverse consequences such as crime, violence, unemployment, and workplace absenteeism. Rising levels of consumption are most pronounced in women and young people, with the latter more prone to heavy binge drinking. There is no doubt that tackling alcohol-related harm is an urgent public-health imperative.
To a large extent the burden attributable to alcohol is preventable and there are proven and effective strategies and interventions to reduce alcohol-related harm. The challenge is getting governments to implement effective alcohol policies in the face of strong industry opposition and widespread public sentiment that alcohol-related harm is a problem confined to a few very heavy drinkers. The Scandinavian countries have traditionally had some of the best-developed policies to control hazardous drinking: government monopolies on alcohol sales, higher taxes on high-alcohol beverages, restrictions on promotion and sale, and tough policies combatting drinking and driving. But these policies have been eroded as a result of deregulation imposed as a condition of European Union membership, and global pressures to allow free trade in all commodities, including alcohol.
Last week, the UK Government released guidance re-commending that young people up to the age of 15 years should avoid alcohol altogether. Similarly, in Australia the National Health and Medical Research Council will be issuing guidelines in late February, recommending that people under the age of 18 years should not consume any alcohol. Certainly, it is desirable to delay the onset age of drinking. US experience showed that raising the minimum legal drinking age to 21 years (with minimum enforcement) substantially reduced deaths from alcohol-related causes. However, education and persuasion are the least effective intervention and so advice by itself in England and Australia will likely make little difference unless it is complemented by policies that focus on price, availability, and affordability at the population level. The UK is often cited as a country that (because of industry influence and the possible political unpopularity of having a drinking age limit) has had an absence of effective alcohol policies, preferring soft measures like education campaigns on issues such as underage drinking, rather than tackling the root of the problem. It is no surprise then that the UK has some of the worst indicators of alcohol-related harm in young people in Europe.
Patterns of global alcohol consumption are changing. The recent increase in consumption in low-income and middle-income countries in southeast Asia and the western Pacific regions are particularly worrying. And the alcohol industry is rapidly infiltrating the markets of Brazil, India, China, and Russia. Last week, news reports of the closure of 800 liquor stores in Rajasthan, India, to curb alcohol-related harm, together with the South African Government shutting down 30 000 illegal shabeens (drinking dens), show positive moves by governments to tackle the problem.
Addressing the harms of alcohol as part of a global-health agenda is gathering momentum. WHO is in the midst of developing a strategy to reduce harmful use of alcohol in consultation and collaboration with member states. That work will be presented to the World Health Assembly in 2010. A Framework Convention on Alcohol Control (a legally binding international treaty) is under discussion. And a forthcoming Lancet Series on alcohol will explore the dimensions of an effective response required to tackle this global-health threat. But countries should not wait. They need to act now to develop comprehensive and effective policies to make a difference.
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Resources:

1. Alcohol Screeing and Brief Intervention http://pubs.niaaa.nih.gov/publications/Practitioner/pocketguide/pocket_guide.htm
2. Alcohol SBI for Trauma Patients http://sbirt.samhsa.gov/documents/SBIRT_guide_Sep07.pdf
3. Screening and Brief Intervention for High-Risk College Student Drinkers http://homepage.psy.utexas.edu/homepage/class/Psy394Q/Behavior%20Therapy%20Class/Assigned%20Readings/Substance%20Abuse/Marlatt98.pdf

Sunday, January 4, 2009

Methadone Evidence Revisited

Dear Friends and Colleagues:
Happy New Year. Attached an interesting recent JAMA article reviewing the issue of Methadone treatment for opioid dependency from a historic perspective.

Several interesting observations which emphasize the issue of the disease concept of addiction and long-term treatment:



"The current scientific consensus is that opioid dependence is a chronic and severe medical disorder, and withdrawal alone is usually followed by rapid relapse."

"During the past 2 decades, evidence has accumulated regarding the neurobiology of opiate dependence. Opiate dependence is now seen as a brain-related disorder with genetic and environmental overlays characteristic of a medical illness. The endorphin system and opioid receptors have now been discovered. Dole was ahead of his time."

"A century ago, however, withdrawal was often considered adequate to treat narcotic addiction, with methods used often more dangerous than withdrawal. Individuals who relapsed were viewed as doing so out of choice rather than necessity."

"Average methadone maintenance doses of 60 to 120 mg or higher have consistently better results than use of lower average doses, especially because heroin purity is now often greater than 40%. Methadone's plasma half-life, once stabilized, averages 24 to 36 hours with a range of 13 to 56 hours. However, as many as 10 days may be needed to reach a steady state, and new patients, either to MMT or given methadone for analgesia, are at risk for fatal overdose.

" Most deaths have been from methadone prescribed for pain rather than from methadone treatment programs."

"In the United States, approximately 260 000 individuals are currently receiving MMT (M. Perrino, written communication, October 2008), although it is estimated that fewer than 10% of individuals who are addicted to heroin and prescription opioids are receiving MMT."


"The benefits of long-term methadone maintenance are borne out by data. Two years of MMT appears to be the minimum duration before attempting withdrawal.Even patients receiving maintenance for long periods with substantial lifestyle changes often relapse after leaving treatment, and death rates are much higher than for individuals who remain in treatment."

"For many patients, therefore, years or even lifetime maintenance may be needed, but there is often patient and family opposition. Office-based medical maintenance has been used on a limited basis for patients stable at least a few years with generally successful results, although some patients increased their use of illicit drugs. "

"Ultimately, the problem of interminable maintenance vs relapse may require learning how to reverse the brain changes associated with addiction. Until then, long-term agonist treatment remains a reasonable alternative."

SUMMARY: We have to apply clinical evidence in the treatment of patients suffering from opioid dependence. Detox SHOULD not be he primary goal BUT treatment of the disease of addiction instead. Medications such as Methadone and Suboxone are useful tools in the treatment approach and have demonstrated to save lives and to prevent relapse.



Yours

Bernd

Bernd Wollschlaeger,MD,FAAFP,FASAM

President, Florida Society of Addiction Medicine

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JAMA. 2008;300(19):2303-2305.

SUMMARY OF THE ORIGINAL ARTICLE

A Medical Treatment for Diacetylmorphine (Heroin) Addiction: A Clinical Trial With Methadone Hydrochloride

Vincent P. Dole, MD, and Marie Nyswander, MD

JAMA. 1965;193(8):646-650.

Twenty-two male patients, addicted to heroin 9.5 years (median), were stabilized using oral methadone hydrochloride and then observed for approximately 1 to 15 months (median, 3 months). The medication had 2 main effects: (1) relief of narcotic hunger (craving); and (2) induction of sufficient tolerance to block the average illegal dose of heroin.

A combination of the methadone treatment and a comprehensive program of rehabilitation was associated with marked improvement in patient problems such as jobs, returning to school, and family reconciliation. No adverse effect other than constipation was found.

The authors note that "careful medical supervision and many social services" were necessary and stressed that "both the medication and supporting program were essential." The small size of the group studied and short duration of the follow-up would best describe this as a promising and exciting but preliminary report.

See PDF for full text of the original JAMA article.

Commentary

The effects of the article by Dole and Nyswander1 are best understood by knowing what preceded it. The current scientific consensus is that opioid dependence is a chronic and severe medical disorder, and withdrawal alone is usually followed by rapid relapse.2 A century ago, however, withdrawal was often considered adequate to treat narcotic addiction, with methods used often more dangerous than withdrawal. Individuals who relapsed were viewed as doing so out of choice rather than necessity.

The frequency of relapse, however, led to the establishment of narcotic clinics to legally provide heroin or morphine to individuals with addiction. By 1923, all these clinics had closed, deemed failures because they did not lead to abstinence. Federal agencies interpreted the 1914 Harrison Act as prohibiting maintenance of individuals with active addiction and threatened or prosecuted physicians doing so. Between 1919 and 1935, approximately 25 000 physicians were indicted under the Harrison Act and 10% were imprisoned. Despite 1921 and 1926 Supreme Court rulings that the act did not forbid such prescribing, most physicians avoided it, ending the role of the medical profession in treating patients with addiction for 4 decades.

Heroin became the street narcotic of choice. During World War II, with heroin scarce and purity as low as 1%, addiction hit a record low. By the late 1940s, the flow of smuggled heroin had resumed, but addicts were more likely younger, from a racial or ethnic minority group, and living in northern impoverished communities. Treatment was scarce, prison common, and relapse likely.3

Methadone Maintenance


Forty years after the last maintenance clinics closed, the 1965 article by Dole and Nyswander landed with a bang.1 Dole, an internist, believed narcotic addiction was a metabolic disease, not very different from diabetes; Nyswander, a psychiatrist, had frustrating years of treating individuals with narcotic addiction with psychotherapy only to see them relapse. Their study,1 conducted in New York City first at the Rockefeller Institute and later moving to Manhattan General Hospital, included 22 participants with heroin addiction. One year later, Dole et al reported empirical data on the induced narcotic blockade.4 Long-term follow-up studies later confirmed that therapeutic success on a larger scale was possible.

Methadone replaced morphine as the preferred agent for heroin withdrawal. As a maintenance agent for treating addiction, methadone prevents withdrawal for 24 to 36 hours, enabling a system in which addicted patients come for treatment once a day, in contrast to the 1920s clinics using short-acting opioids.

Following the 1965 article,1 scientists systematically expanded the science behind methadone maintenance treatment (MMT). Large-scale programs using more cost-effective induction methods opened in New York City, and the US Food and Drug Administration approved a limited use of methadone in large research programs.5

In 1970, the federal government faced 2 major heroin-related problems: heroin use and associated crime was increasing, especially in urban areas; and soldiers in Vietnam were using heroin. Concerned about possible increased crime when these soldiers returned home and influenced by the early success of DuPont's Narcotics Treatment Administration in reducing crime by treating individuals with heroin addiction,6 President Nixon announced the war on drugs on June 17, 1971, created the Special Action Office for Drug Abuse Prevention (SAODAP), and hired Jerome Jaffe to be its first director. This new federal structure was charged with coordinating and rapidly expanding drug treatment, including changing existing regulations.5

Even as SAODAP and New York City moved to expand MMT, strong reaction began against it, fueled partly by reports of methadone-related deaths and diversion, but primarily by its substituting one addiction for another. Psychosocial program advocates opposed MMT as likely to reduce concerns about poverty and social ills. The director of a therapeutic community remarked, "I think methadone is a great idea. We should give money to bank robbers, women to rapists, and methadone to addicts."7

In those first 2 years, more federally supported treatment capacity developed than in the previous 50 years. In 1974, two-thirds of the $750 million drug budget was devoted to treatment, research, and prevention, compared with the recent 25 years during which two-thirds of the budget targeted supply reduction.5


Positive Outcomes of MMT

Numerous studies have demonstrated the effectiveness of MMT for reducing illicit opioid use, morbidity and mortality, risk of human immunodeficiency virus (HIV) infection, illegal activities, and improving overall functioning. Patients in MMT had a 1-year mortality rate of 1% compared with 8% among patients who discontinued treatment.8 In a 1993 prospective study conducted in Philadelphia, Pennsylvania, HIV seroconversion rates were 4 times higher among individuals who were actively using street heroin compared with patients receiving MMT.9 Risk decreased in relation to length of time continuously receiving MMT; risk of hepatitis B and hepatitis C also was reduced but to a much lower extent.9

In a 1991 study, crime days per year among individuals addicted to narcotics decreased more than 70% while receiving MMT.10 In a random assignment study, patients in the standard and enhanced treatment groups had marked reductions in illicit opiate use and improvements in overall functioning compared with the minimal counseling group.11 However, the increase of for-profit MMT centers (often realizing very large profits), and decreased funding for nonprofit centers left many programs inadequately staffed. This remains a major unresolved public health problem.

Average methadone maintenance doses of 60 to 120 mg or higher have consistently better results than use of lower average doses, especially because heroin purity is now often greater than 40%. Methadone's plasma half-life, once stabilized, averages 24 to 36 hours with a range of 13 to 56 hours. However, as many as 10 days may be needed to reach a steady state, and new patients, either to MMT or given methadone for analgesia, are at risk for fatal overdose. Most deaths have been from methadone prescribed for pain rather than from methadone treatment programs.

Although MMT has been lifesaving for thousands of individuals, it is not a panacea. High levels of psychopathology remain. Abuse of cocaine and benzodiazepines and disruptive behavior are problems in many programs. Many patients do not change their behavior even when services are available. What to do under such circumstances remains contentious, given the likely severe postdischarge consequences vs the effect on other patients and the possibility that more intensive residential intervention might be helpful.

During the past 2 decades, evidence has accumulated regarding the neurobiology of opiate dependence. Opiate dependence is now seen as a brain-related disorder with genetic and environmental overlays characteristic of a medical illness. The endorphin system and opioid receptors have now been discovered. Dole was ahead of his time.1, 4, 12

Safety

Studies on MMT in the 1970s by Kreek found no long-term damage to the heart, kidneys, liver, or lungs.13 Long-acting maintenance medications normalized the neuroendocrine alterations induced by short-acting opioids12 with minimal psychoactive impairment. MMT has been shown not to impair driving ability. In the past decade, it was found that methadone, especially at high doses, when beginning treatment, or when combined with certain drugs, may lead to QTc prolongation and possibly to torsade de pointes, a potentially fatal cardiac arrhythmia. A black box warning was added to the prescribing information for methadone in December 2006. However, the clinical significance of this abnormality is not yet clear regarding deaths.

Federal Regulations

MMT is one of the most heavily regulated medical treatments in the United States.5 With few exceptions, methadone may only be dispensed for opioid withdrawal or maintenance by certified opioid treatment programs. An increasing number of take-home doses is permitted, depending on the patient's history of illicit drug use and employment, with a maximum 1-month supply after 2 years. Regulations and decreased public financing have made it more difficult to start or expand programs. An Institute of Medicine review14 concluded, " . . . current policy puts too much emphasis on protecting society from methadone, and not enough on protecting society from the epidemic of addiction, violence, and infections that methadone can help reduce." However, regulation that is too lenient may lead to worsened problems and increased hostility; a balance is needed.

Stigma

In the late 1980s, the backlash against MMT became stronger. Community complaints about loitering and bartering of drugs outside clinics exacerbated the hostile environment. Complaints often coincided with decreased ancillary supports.

In 1988, the White House Conference for a Drug-Free America, vehemently antimethadone, demonized methadone and the National Institute on Drug Abuse and called for a congressional investigation.7 In 1990, the Office of National Drug Control Policy reversed this position, and its White Paper on treatment stated clearly that methadone maintenance was both legitimate and an important part of the spectrum of drug abuse treatment.7 Ironically, even though 12-step programs have often been hostile to MMT,15 Dole, a friend of the cofounder of Alcoholics Anonymous recounted, "He [Bill W.] suggested that in my future research, I should look for an analogue of methadone, a medication that would relieve the alcoholic's sometimes irrestible craving and enable him to progress in AA toward social and emotional recovery. . . . "15

In the United States, approximately 260 000 individuals are currently receiving MMT (M. Perrino, written communication, October 2008), although it is estimated that fewer than 10% of individuals who are addicted to heroin and prescription opioids are receiving MMT. Worldwide, about 1 million individuals are receiving MMT; in some countries such as Russia, government opposition to agonist maintenance prevents its use even when high HIV rates exist.

The long-acting sublingual partial agonist buprenorphine, a Schedule III opioid, has been available since 2002 for office-based prescribing by physicians with special training5 and with current limits of 100 patients per physician. Approximately 140 000 patients are now receiving maintenance using buprenorphine (R.E. Johnson, written communication, October 2008) and results to date appear comparable to MMT albeit with somewhat different populations. It is not clear whether it will be any easier to remain abstinent after withdrawal from buprenorphine treatment than from MMT, especially if inadequate ancillary support is provided. While buprenorphine's formulation makes overdose or diversion to parenteral use less likely, like all ยต agonists, this drug has that possibility and limited diversion is already occurring.

Methadone: Terminable or Interminable

The benefits of long-term methadone maintenance are borne out by data.2 Two years of MMT appears to be the minimum duration before attempting withdrawal.5 Even patients receiving maintenance for long periods with substantial lifestyle changes often relapse after leaving treatment, and death rates are much higher than for individuals who remain in treatment. For many patients, therefore, years or even lifetime maintenance may be needed, but there is often patient and family opposition. Office-based medical maintenance has been used on a limited basis for patients stable at least a few years with generally successful results, although some patients increased their use of illicit drugs. This approach avoids the clinic problem of mixing stable and unstable patients but the number of eligible stable patients appears limited. Ultimately, the problem of interminable maintenance vs relapse may require learning how to reverse the brain changes associated with addiction. Until then, long-term agonist treatment remains a reasonable alternative.


AUTHOR INFORMATION

Corresponding Author: Herbert D. Kleber, MD, Columbia University College of Physicians and Surgeons, Division on Substance Abuse, The New York State Psychiatric Institute, 1051 Riverside, PI Unit 66, New York, NY 10032 (hdk3@columbia.edu).

Financial Disclosure: Dr Kleber reports serving as a consultant and also receiving an unrestricted educational grant from Reckitt Benckiser for the Columbia Buprenorphine Program through Columbia University.

Funding/Support: Support for preparation of this article was provided under: National Institute on Drug Abuse grant 5KO5 DA014284.

Additional Contributions: Progress in this area would not have been possible without the efforts and accomplishments of the many individuals who played important roles over the 40 years in expanding the science and growth of methadone maintenance. Their contributions made this potentially life-saving modality available to many.

Author Affiliations: Columbia University College of Physicians and Surgeons, Division on Substance Abuse, The New York State Psychiatric Institute, New York.


REFERENCES

1. Dole VP, Nyswander MA. Medical treatment for diacetylmorphine (heroin) addiction: a clinical trial with methadone hydrochloride. JAMA. 1965;193(8):646-650. FULL TEXT | PUBMED
2. National Institutes of Health. Effective medical treatment of opiate addiction. NIH Consensus Statement. 1997;15(6):1-38. PUBMED
3. Jonnes J. Hep-Cats, Narcs, and Pipe Dreams. New York, NY: Scribner; 1996.
4. Dole VP, Nyswander ME, Kreek MJ. Narcotic blockade. Arch Intern Med. 1966;118(4):304-309. FULL TEXT | ISI | PUBMED
5. Jaffe JH, O’Keeffe C. From morphine clinics to buprenorphine: regulating opioid agonist treatment of addiction in the United States. Drug Alcohol Depend. 2003;70(2 suppl):S3-S11. PUBMED
6. DuPont RL. Heroin addiction in the nation's capital, 1966-1973. In: Musto DF, ed. One Hundred Years of Heroin. Westport, CT: Auburn House; 2002:67-90.
7. Kleber HD. Methadone: the drug, the treatment, the controversy. In: Musto DF, ed. One Hundred Years of Heroin. Westport, CT: Auburn House; 2002:149-158.
8. Zanis DA, Woody GE. One year mortality rates following methadone treatment discharge. Drug Alcohol Depend. 1998;52(3):257-260. FULL TEXT | ISI | PUBMED
9. Metzger DS, Woody GE, McLellan AT; et al. Human immunodeficiency virus seroconversion among intravenous drug users in and out of treatment: an 18 month prospective follow-up. J Acquir Immune Defic Syndr. 1993;6(9):1049-1056. ISI | PUBMED
10. Ball JC, Ross A. The Effectiveness of Methadone Maintenance Treatment. New York, NY: Springer Verlag; 1991.
11. McLellan AT, Arndt IO, Metzger DS; et al. The effects of psychosocial services in substance abuse treatment. JAMA. 1993;269(15):1953-1960. ABSTRACT
12. Dole VP. Implications of methadone maintenance for theories of narcotic addiction. JAMA. 1988;260(20):3025-3029. ABSTRACT
13. Kreek MJ. Medical complications in methadone patients. Ann N Y Acad Sci. 1978;311:110-134. PUBMED
14. Rettig RA, ed, Yarmolinsky A, ed. Federal Regulation of Methadone Treatment. Washington, DC: Institute of Medicine National Academy Press; 1995.
15. Dole VP. Addiction as a public health problem. Alcohol Clin Exp Res. 1991;15(5):749-752. PUBMED

Saturday, December 6, 2008

Baclofen for the Treatment of Alcoholism?

Dear Friends and Colleagues:
A recent BBC news report highlighted a book written by a French cardiologist describing his " cure from alcoholism" utilizing Baclofen.
Attached you find the news report and a reference to a SMALL double-blind randomized trial suggesting a beneficial effect of Baclofen for the treatment of alcoholism.
Looking forward to your comments.
Yours
Bernd

Bernd Wollschlaeger,MD,FAAFP,FASAM
President, Florida Society of Addiction Medicine

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BBC NEWS
France abuzz over alcoholic 'cure'

By Hugh Schofield
Paris

An eminent French cardiologist has triggered an impassioned debate in the medical world over his claim to have discovered a cure for alcoholism.

Dr Olivier Ameisen, 55, one of France's top heart specialists, says he overcame his own addiction to alcohol by self-administering doses of a muscle-relaxant called baclofen.

He has now written a book about his experience - Le Dernier Verre (The Last Glass) - in which he calls for clinical trials to test his theory that baclofen suppresses the craving for drink.

Widespread media coverage of his book in France has led to a rush of demands from alcoholics for similar treatment, and some doctors have reported unexpected successes after prescribing it.

But many other specialists are sceptical, warning of the dangers of so-called miracle cures.

'Needed alcohol'

Dr Ameisen was associate professor of cardiology at New York's Cornell University, and in 1994 he opened a profitable private practice in Manhattan.

But, stricken by an overwhelming feeling of inadequacy - he says he felt like "an impostor waiting to be unmasked" - he found relief in large quantities of whisky and gin.

"I detested the taste of alcohol. But I needed its effects to exist in society," he says in Le Dernier Verre, which comes out in English next month.

Dr Ameisen says he tried every known remedy to end his dependence. Between 1997 and 1999 he spent a total of nine months confined in clinics - but nothing worked.

Fearing for his own patients, he gave up his practice and returned to Paris. Then, in 2000, he read an article about an American man who was treated with baclofen for muscle spasms and found that it eased his addiction to cocaine.

Further investigation uncovered research showing that the drug worked on rats to cut addiction to alcohol or cocaine.

But, strangely, Dr Ameisen found that baclofen was unknown to specialists on dependence.

In March 2002 he began treating himself with daily doses of five milligrams.

"The first effects were a magical muscular relaxation and baby-like sleep," he says. Almost immediately he also detected a lessening in his desire for drink.

Gradually, he increased the daily dosage to a maximum of 270mg, and found that he was "cured". Today he continues to take 30 to 50mg a day.

"Mine is the first case in which a course of medicine has completely suppressed alcohol addiction," he says.

"Now I can have a glass and it has no effect. Above all, I no longer have that irrepressible need to drink."

Not licensed

With its eye-catching message, Le Dernier Verre has been an autumn best-seller - prompting thousands of recovering alcoholics to ask to be prescribed with baclofen.

Some doctors have decided to ignore the fact that the drug is not authorised for treating alcoholism, and report exciting results.

"I prescribed it to two alcoholics who were really at the end of the road. To be honest, it was pretty miraculous," says Dr Renaud de Beaurepaire of the Paul-Guiraud hospital at Villejuif near Paris.

In Geneva, Dr Pascal Garche put 12 patients on baclofen, of whom seven came through reporting marked improvements.

"I have never had reactions like this before. We cannot ignore findings such as this - the book is going to set the cat among the pigeons," he said.

However, many specialists fear that media excitement over Dr Ameisen's theory is obscuring the complex nature of alcoholism.

"Encouraging people to think that there is a miracle molecule is to completely misunderstand the nature of alcoholism, and is extremely irresponsible, " says Dr Michel Reynaud of Paul-Brousse hospital in Paris.

"We need comprehensive tests to determine how this drug acts, if it is effective and at what dosage, and if it is genuinely harmless in the longer term, " says Alain Rigaud, president of the National Association for the Prevention of Alcoholism and Addiction.

"But even if it turns out to work, that does not mean a drug alone is the solution."
Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/europe/7768141.stm

Published: 2008/12/06 16:44:46 GMT
======================================================================================

PROCEEDINGS OF A SYMPOSIUM ENTITLED: 'GABAB RECEPTORS: A TARGET OF NEW TREATMENTS FOR ALCOHOLISM AND DRUG ABUSE'
BACLOFEN EFFICACY IN REDUCING ALCOHOL CRAVING AND INTAKE: A PRELIMINARY DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY

Giovanni Addolorato*, Fabio Caputo2, Esmeralda Capristo, Marco Domenicali2, Mauro Bernardi2, Luigi Janiri1, Roberta Agabio3, Giancarlo Colombo4, Gian Luigi Gessa3,4,5 and Giovanni Gasbarrini

Institute of Internal Medicine and
1 Institute of Psychiatry, Catholic University of Rome, Rome,
2 ‘G. Fontana’ Centre for the Study and Treatment of the Alcohol Addiction, University of Bologna, Bologna,
3 ‘Bernard B. Brodie’ Department of Neuroscience, University of Cagliari,
4 C.N.R. Institute of Neurogenetics and Neuropharmacology, Cagliari and
5 Neuroscienze S.c.a r.l., Cagliari, Italy

Received 15 March 2002; first review notified 19 April 2002; accepted 22 April 2002

ABSTRACT

— Aims: The {gamma}-aminobutyric acid (GABAB) receptor agonist, baclofen, has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans. The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design. Methods: A total of 39 alcohol-dependent patients were consecutively enrolled in the study. After 12–24 h of abstinence from alcohol, patients were randomly divided into two groups. Twenty patients were treated with baclofen and 19 with placebo. Drug and placebo were orally administered for 30 consecutive days. Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days, divided into three daily doses. Patients were monitored as out-patients on a weekly basis. At each visit alcohol intake, abstinence from alcohol, alcohol craving and changes in affective disorders were evaluated.
Results: A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen, compared to the placebo, group. A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group; likewise, alcohol intake was reduced in the baclofen group. A decrease in state anxiety was found in the baclofen compared to the placebo group. No significant difference was found between the two groups in terms of current depressive symptoms. Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects. No patient was affected by craving for the drug and/or drug abuse.
Conclusions: Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics. With the limits posed by the small number of subjects involved, the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations.


=======================================================================================


Baclofen Use in the Treatment of Alcohol Delirium Tremens

We read with great interest the recent meta-analysis by Mayo-Smith et al1 about the management of alcohol withdrawal delirium (AWD). The authors included new clinical data on the management of AWD, ranging from a single case report to a prospective randomized trial from 1966 to 2001. Since the time considered, among the possible new drugs useful in the management of AWD, the authors did not mention the possible utility of the {gamma}-aminobutyric acid {beta}(GABA receptor agonist baclofen. Baclofen is able to suppress alcohol withdrawal symptoms both in animals2 and in humans3 and may be effective in reducing voluntary alcohol intake in alcohol-preferring rats2 and alcohol craving and intake in alcoholic individuals.4 We recently described a patient in whom AWD was rapidly and completely suppressed by baclofen administration.5 We believe that prior clinical data suggest that baclofen could be a useful new drug in the treatment of AWD, although future controlled clinical trials are needed to confirm its safety and effectiveness.


AUTHOR INFORMATION

Correspondence: Dr Addolorato, Institute of Internal Medicine, Catholic University, Gemelli Hospital, L.go A. Gemelli 8, 00168-Rome, Italy (g.addolorato@rm.unicatt.it).

Lorenzo Leggio, MD; Ludovico Abenavoli, MD; Fabio Caputo, MD; Giovanni Gasbarrini, MD; Giovanni Addolorato, MD


REFERENCES

1. Mayo-Smith MF, Beecher LH, Fisher TL, et al, Working Group on the Management of Alcohol Withdrawal Delirium, Practice Committee, American Society of Addiction Medicine. Management of alcohol withdrawal delirium: an evidence-based practice guideline. Arch Intern Med. 2004;164:1405-1412. FREE FULL TEXT
2. Colombo G, Agabio R, Carai MAM, et al. Ability of baclofen in reducing alcohol intake and withdrawal severity, I: preclinical evidence. Alcohol Clin Exp Res. 2000;24:58-66. FULL TEXT | ISI | PUBMED
3. Addolorato G, Caputo F, Capristo E, et al. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002;112:226-229. FULL TEXT | ISI | PUBMED
4. Addolorato G, Caputo F, Capristo E, et al. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002;37:504-508. FREE FULL TEXT
5. Addolorato G, Leggio L, Abenavoli L, et al. Suppression of alcohol delirium tremens by baclofen administration: a case report. Clin Neuropharmacol. 2003;26:258-262. PUBMED

Arch Intern Med. 2005;165:586.