A controlled trial of buprenorphine treatment for opium dependence: the first experience from Iran

Aims: To evaluate the effect of a 4 mg/day sublingual dose of buprenorphine in the maintenance treatment of opium dependence in comparison with a 1 mg/day dose over an 18-week treatment period. As a secondary objective, the results were determined concurrently for subjects treated with a 2 mg,day dose. Design: Subjects were assigned randomly to three dosage groups. Participants: 330 consecutive (320 men and 10 women) opium addicts who met the DSM-IV criteria for opioid dependence and were seeking treatment. Intervention: Subjects received a 1, 2 or 4 mg/day dose of buprenorphine and were treated in an outpatient clinic where they also received a weekly 1-hour clinical counseling session. Measurements: Addiction Severity Index, retention in treatment, and illegal opioid use as determined by random urine testing. Findings: The mean age was 37.5 years (SD = 11.4, range 19-72). Overall, 194 (58.8%,) of the patients completed the 18 week study. Completion rates by dosage groups were 47.3% for the 1 mg group, 58.2% for the 2 mg group and 70.9% for the 4 mg group (chi(2) = 12.7, df = 2, P = 0.0017). Conclusions: The results support the efficacy and safety of buprenorphine for opium addiction and suggest that an adequate dose of buprenorphine would help to increase the success rate. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.