Comparative Safety and Side Effect Profiles of Buprenorphine and Methadone in the Outpatient Treatment of Opioid Dependence

Objectives: This study presents the comparative safety and side effect profiles of buprenorphine and methadone, including gender relationships, from a clinical trial comparing buprenorphine and methadone in the outpatient treatment of opioid dependence. Methods: One hundred sixty-four opioid dependent volunteers age 18–50 years were randomized to buprenorphine (n = 84) or to methadone (n = 80) for 16 weeks of maintenance. Liver function tests, vital signs, patient self-reports of common medication side effects, and medical reports of adverse effects were assessed. Results: Buprenorphine and methadone produced similar profiles of safety and side effects, and there were few clinically significant gender differences. SGOT and SGPT liver test abnormalities did not significantly differ between buprenorphine and methadone maintained subjects. Conclusions: These results along with results from studies of the efficacy of buprenorphine provide further evidence supporting the use of buprenorphine in the treatment of opioid dependence. There is no evidence that buprenorphine is selectively associated with abnormal liver function compared with methadone.