A Controlled Trial of Buprenorphine Treatment for Opioid Dependence

Rolley E. Johnson, PharmD; Jerome H. Jaffe, MD; Paul J. Fudala, PhD
JAMA. 1992;267(20):2750-2755. doi:10.1001/jama.1992.03480200058024.
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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)


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