May 27, 1992

A Controlled Trial of Buprenorphine Treatment for Opioid Dependence

Author Affiliations

From the Addiction Research Center, National Institute on Drug Abuse, Baltimore, Md. Dr Johnson is now with the Department of Psychiatry, The Johns Hopkins School of Medicine, Baltimore. Dr Jaffe is now with the Office of Treatment Improvement, Alcohol, Drug Abuse, and Mental Health Administration, Rockville, Md. Dr Fudala is now with the Department of Psychiatry, University of Pennsylvania School of Medicine and the Department of Veterans Affairs Medical Center, Philadelphia.

JAMA. 1992;267(20):2750-2755. doi:10.1001/jama.1992.03480200058024

Objective.  —To assess the efficacy of buprenorphine for short-term maintenance/detoxification.

Design.  —A randomized, double-blind, parallel group study comparing buprenorphine, 8 mg/d, methadone, 60 mg/d, and methadone, 20 mg/d, in a 17-week maintenance phase followed by an 8-week detoxification phase.

Setting.  —Outpatient facilities at the Addiction Research Center, Baltimore, Md.

Patients.  —One hundred sixty-two volunteers seeking treatment for opioid dependence.

Intervention.  —In addition to the medication, counseling using a relapse prevention model was offered but not required.

Primary Outcome Measures.  —Retention time in treatment, urine samples negative for opioids, and failure to maintain abstinence.

Results.  —Throughout the maintenance phase, retention rates were significantly greater for buprenorphine (42%) than for methadone, 20 mg/d (20%, P<.04); the percentage of urine samples negative for opioids was significantly greater for buprenorphine (53%, P<.001) and methadone, 60 mg/d (44%, P<.04), than for methadone, 20 mg/d (29%). Failure to maintain abstinence during the manintenance phase was significantly greater for methadone, 20 mg/d, than for buprenorphine (P<.03). During the detoxification phase, no differences were observed between groups with respect to urine samples negative for opioids. For the entire 25 weeks, retention rates for buprenorphine (30%, P<.01) and methadone, 60 mg/d (20%, P<.05), were significantly greater than for methadone, 20 mg/d (6%). All treatments were well tolerated, with similar profiles of self-reported adverse effects. The percentages of patients who received counseling did not differ between groups.

Conclusions.  —Buprenorphine was as effective as methadone, 60 mg/d, and both were superior to methadone, 20 mg/d, in reducing illicit opioid use and maintaining patients in treatment for 25 weeks.(JAMA. 1992;267:2750-2755)