BUPRENORPHINE MAINTENANCE TREATMENT OF OPIATE DEPENDENCE - A MULTICENTER, RANDOMIZED CLINICAL-TRIAL

Aims. To evaluate the safety and efficacy of an 8 mg/day sublingual do se of buprenorphine in the maintenance treatment of heroin addicts by comparison with a 1 mg/day dose over a 16-week treatment period. As a secondary objective, outcomes were determined concurrently for patient s treated with two other dose levels. Design. Patients were randomized to four dosage groups and treated double-blind. Setting. Twelve outpa tient opiate maintenance treatment centers throughout the United State s. Participants. Two hundred and thirty-nine women and 497 men who met the DSM-III-R criteria for opioid dependence and were seeking treatme nt. Intervention. Patients received either 1, 4, 8 or 16 mg/day of bup renorphine and were treated in the usual clinical context, including a 1-hour weekly clinical counseling session. Measurement. Retention in treatment, illicit opioid use as determined by urine toxicology, opioi d craving and global ratings by patient and staff. Safety outcome meas ures were provided by clinical monitoring and by analysis of the repor ted adverse events. Findings. Outcomes in the 8 mg group were signific antly better than in the 1 mg group in all four efficacy domains. No d eaths occurred in either group. The 8 mg group did not show an increas e in the frequency of adverse events. Most reported adverse effects we re those commonly seen in patients treated with opioids. Conclusions. The findings support the safety and efficacy of buprenorphine and sugg est that an adequate dose of buprenorphine will be a useful addition t o pharmacotherapy.