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.