Thursday, November 6, 2008

Buprenorphine in the News

Dear Friends and Colleagues:
Attached the results of a recently published study to evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.
Not surprisingly the results indicate that opioid-positive urine test results, retention in the trial, self-reported opioid use, injecting behavior, enrollment in nonstudy treatment, and use of cocaine and marijuana strongly favored patients in the 12-week buprenorphine-naloxone group during weeks 1 through 12. They had much less use of opioids, cocaine, and marijuana; much better treatment retention; and much less injecting and need for additional treatment while on medication.
In a commentary ( see http://jama.ama-assn.org/cgi/content/full/300/17/2057) David A Fiellin,MD points out that

" The results of this trial should prompt clinicians to use caution when tapering buprenorphine-naloxone in adolescent patients who receive this medication. Supportive counseling; close monitoring for relapse; and, in some cases, naltrexone should be offered following buprenorphine tapers. From a research perspective, additional efforts are needed to provide a stronger evidence base from which to make recommendations for adolescents who use opioids. There is limited research on prevention of opioid experimentation and effective strategies to identify experimentation and intercede to disrupt the transition from opioid use to abuse and dependence. No information is available regarding the efficacy of treatment with medications such as methadone or buprenorphine-naloxone compared with nonagonist approaches (eg, naltrexone) or nonpharmacologic approaches such as short-term rehabilitation or partial hospitalization programs."

"The high rate of relapse seen with both medication taper protocols in the current trial involving opioid-dependent adolescents, combined with the adverse social, legal, and infectious consequences of opioid dependence—and the risk for overdose with relapse—makes the need for rigorous evidence in this area urgent. These findings are another important reminder that there are no quick fixes for opioid dependence."

In his commentary Fiellin also remarks that

" There is appropriate concern about providing these medications to young individuals despite the substantial risks of opioid dependence. This concern stems from the fact that these medications prolong a state of opioid physical dependence and therefore may limit an adolescent's chance for obtaining abstinence without an opioid-based medication. "

I do not agree with his judgment because in my opinion we are using methadone and buprenorphine to provide a withdrawal free condition which then can be used to apply all the other non-pharmacological approaches to adjust and improve their overall functional state ( personal, professional, social, financial, family etc.). There is no room for any ideological or orthodox thinking in treating patients suffering from the brain disease of addiction. Do we also detox patients from antidepressants or antipsychotics when they are suffering from mental diseases?
Looking forward to your comments.
Yours
Bernd
Bernd Wolllschlaeger,MD,FAAFP,FASAM
President,Florida Society of Addiction Medicine




JAMA November 5th,2008

Extended vs Short-term Buprenorphine-Naloxone for Treatment of Opioid-Addicted Youth
A Randomized Trial

George E. Woody, MD; Sabrina A. Poole, MS; Geetha Subramaniam, MD; Karen Dugosh, PhD; Michael Bogenschutz, MD; Patrick Abbott, MD; Ashwin Patkar, MD; Mark Publicker, MD; Karen McCain, MSN, FNP; Jennifer Sharpe Potter, PhD, MPH; Robert Forman, PhD; Victoria Vetter, MD; Laura McNicholas, MD, PhD; Jack Blaine, MD; Kevin G. Lynch, PhD; Paul Fudala, PhD
JAMA. 2008;300(17):2003-2011.

ABSTRACT


Context The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful.

Objective To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.

Design, Setting, and Patients Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox).

Interventions Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling.

Main Outcome Measure Opioid-positive urine test result at weeks 4, 8, and 12.

Results: The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (22 = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; 21 = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (21 = 18.45, P < .001), less injecting (21 = 6.00, P = .01), and less nonstudy addiction treatment (21 = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12.

Conclusions: Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence.

Trial Registration clinicaltrials.gov Identifier: NCT00078130

See http://jama.ama-assn.org/cgi/content/full/300/17/2003 for the full text of the article.

Tuesday, November 4, 2008

Independent Practice of Addiction Medicne

Thank you for the comment.
The independent practice of addiction medicine implies that we want to provide the physicians the tools (practice management, risk management etc.) to provide practice-based addiction medicine care modalities in their practices. The availability of Suboxone, Revia, etc. and the desire of patients to be treated in an outpatient settings provides a unique opportunity to solidify and expand our practices. Lets dare to think out-of-the box. Looking forward to your comments.
Bernd

Sunday, November 2, 2008

FSAM NEWS

Dear Friends and Colleagues:
As your President I have set myself two simple but, nevertheless, challenging goals:

1. to improve the communication with our members.
2. to assist and support the independent practice of addiction medicine.

COMMUNICATION:
• I can be reached 24/7 via cell phone (305) 940-8717, or via e-mail at info@miamihealth.com, or via http://twitter.com/dadedoc.
• I am willing to travel to your local hospital to talk about ASAM, FSAM and the practice of addiction medicine.
• I am available for CME programs or can support you in developing educational outreach programs.

PRACTICE SUPPORT:

• As a member of the Medical Specialty Action Group(MSAG) I participated in the formation of the American Board of Addiction Medicine. The Board is now an independent entity and held is first meeting in April 2008. The formation of ABAM is an important milestone in the recognition of Addiction Medicine as a medical specialty. For more information see http://www.asam.org/CMS/images/PDF/AboutASAM/2008_Number-2_ABAM%20Issue.pdf .
• Parity Legislation: On October 3, 2008, President Bush signed HR 1424 into law. This bill, commonly known as the Wall Street "bailout bill" included a previously approved tax extenders bill as well as the compromise parity legislation. The Parity provisions contained is also known as Section 511:Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. It amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act, and the Internal Revenue Code to require a group health plan that provides both medical and surgical benefits and mental health or substance use disorder benefits to ensure that: (1) the financial requirements, such as deductibles and copayments, applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant financial requirements applied to substantially all medical and surgical benefits covered by the plan; (2) there are no separate cost sharing requirements that are applicable only with respect to mental health or substance use disorder benefits; (3) the treatment limitations applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant treatment limitations applied to substantially all medical and surgical benefits covered by the plan; and (4) there are no separate treatment limitations that are applicable only with respect to mental health or substance use disorder benefits.
• Requires the criteria for medical necessity determinations and the reason for any denial of reimbursement or payment for services made under the plan with respect to mental health or substance use disorder benefits to be made available by the plan administrator.
• Requires the plan to provide out-of network coverage for mental health or substance use disorder benefits if the plan provides coverage for medical or surgical benefits provided by out-of network providers.
• Exempts from the requirements of this Act a group health plan if the application of this Act results in an increase for the plan year of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits by an amount that exceeds 2% for the first plan year and 1% for each subsequent plan year. Requires determinations as to increases in actual costs under a plan to be made and certified by a qualified and licensed actuary.
• Requires determinations for such an exemption to be made after such plan has complied with this Act for the first six months of the plan year.
• Sets forth requirements for notifications of exemptions under this Act, including notification of the Secretary of Health and Human Services, the appropriate state agencies, and participants and beneficiaries in the plan.
• Authorizes the Secretary and the appropriate state agency to audit the books and records of a group health plan relating to an exemption.
• Directs the Secretary to: (1) report to the appropriate congressional committees on compliance of group health plans with the requirements of this Act; and (2) publish guidance and information concerning the requirements of this Act and provide assistance concerning such requirements and the continued operation of applicable state law.
• Requires the Comptroller General to report to Congress on the specific rates, patterns, and trends in coverage and exclusion of specific mental health and substance use disorder diagnoses by health plans and health insurance.Most plans will begin implementing the new requirements in January 2010. This act represents a milestone in our struggle for parity and we need to closely monitor its implementation.

Please be advised that ASAM allocated significant financial resources to accomplish these two important goals: ABAM formation, Parity Bill.

Therefore, the ASAM Board decided to increase the membership dues to $390 for regular membership. This increase may be met with criticism but please rest assured that each and every dollar will be used to expand and strengthen our organization.

I look forward to your comments and please join our organization or renew your membership.

I also hope that I can count on your support for my candidacy as Region X Regional Director. You should have received your ballot already and please vote either via paper ballot or online.

Looking forward speaking with you soon.

Yours truly,
Bernd Wollschlaeger,MD,FAAFP,FASAM
President,Florida Society of Addiction Medicine
President, Dade County Medical Association

ASAM Elections

Dear Friends and Colleagues:
I hope that I can count on your support for my candidacy as Region X Regional Director. You should have received your ballot already and please vote either via paper ballot or online.
Yours truly,
Bernd Wollschlaeger,MD,FAAFP.FASAM