A CONTROLLED TRIAL OF BUPRENORPHINE TREATMENT FOR OPIOID DEPENDENCE

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 maintenance 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.