A Randomized, Clinical Trial of Buprenorphine Maintenance Treatment for Iranian Patients With Opioid Dependency

Objectives This study assessed the effect of a 4-mg/d sublingual dosage of buprenorphine in the maintenance treatment of Iranian patients with opioid dependency by comparison with a 1-mg/d dosage over a 24-week treatment period. As a secondary objective, results were determined concurrently for patients treated with a 2-mg/d dosage. Methods Patients were randomized to three dosage groups. The participants included 420 consecutive patients (407 men and 13 women) with opioid dependency who met the criteria for opioid dependence of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and were seeking treatment. Patients received a 1-, 2-, or 4-mg/d dosage of buprenorphine and were treated in an outpatient clinic (in Shiraz, Iran, with a population of approximately 1.5 million), including a 1-hour weekly clinical counseling session. Measurements included Addiction Severity Index, retention in treatment, and illegal opioid use as determined by random urine toxicology. Results The mean age was 36.3 years (SD, 11.3; range, 16–72). Overall, 237 (56.4%) of the patients completed the 24-week study. Completion rates by dosage group were 45.7% for the 1-mg group, 55.7% for the 2-mg group, and 62.9% for the 4-mg group (χ 2 = 14.0, df = 2, P < 0.001). No sex difference was observed (χ 2 = 0.04, df = 1, P = 0.84). Conclusions The results support the efficacy and safety of buprenorphine for opioid dependence and suggest that an adequate dosage of buprenorphine is strongly recommended for Iranian patients with opioid dependence to increase their success rate.