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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.

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

Author Affiliations: Department of Psychiatry, University of Pennsylvania, Philadelphia (Drs Woody, Forman, McNicholas, Lynch, and Fudala and Ms Poole); Treatment Research Institute, Philadelphia (Drs Woody, Dugosh, and Lynch); Division of Child and Adolescent Psychiatry, Johns Hopkins University, Baltimore, Maryland (Dr Subramaniam); Department of Psychiatry (Drs Bogenschutz and Abbott) and Center on Alcoholism, Substance Abuse, and Addictions (Dr Bogenschutz); University of New Mexico, Albuquerque; Addiction and Substance Abuse Programs, University of New Mexico Health Sciences Center, Albuquerque (Dr Abbott); Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina (Dr Patkar); Mercy Recovery Center, Westbrook, Maine (Dr Publicker); Duke Addictions Program, Duke University, Durham (Ms McCain); Harvard Medical School, Boston, Massachusetts (Dr Potter); McLean Hospital, Belmont, Massachusetts (Dr Potter); Division of Pediatric Cardiology, Children's Hospital of Philadelphia (Dr Vetter); Veterans Affairs Medical Center, Philadelphia (Drs Woody, McNicholas, and Fudala); and Center for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, Maryland (Dr Blaine). Dr Forman is now with Alkermes Inc, Cambridge, Massachusetts, and Dr Fudala is now with Reckitt Benckiser Pharmaceuticals Inc, Richmond, Virginia.

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