A PLACEBO-CONTROLLED CLINICAL-TRIAL OF BUPRENORPHINE AS A TREATMENT FOR OPIOID DEPENDENCE

Large-scale placebo controlled clinical trials assessing the efficacy of medications for the treatment of drug dependence have generally bee n limited to alcohol, cocaine and nicotine dependent populations. The purpose of the present study was to assess the early (1-2 week) clinic al effectiveness of buprenorphine versus placebo in an opioid dependen t population. The study used a parallel-group design with a behavioral choice component to compare buprenorphine (a mu-opioid partial agonis t) to placebo for the treatment of opioid dependence. Opioid dependent volunteer patients participated in a 14-day study to assess the effec tiveness and patient acceptance of this new pharmacotherapy for the tr eatment of opioid dependence. Patients were randomly assigned to place bo (n = 60) or 2 mg (n = 60) or 8 mg (n = 30) daily sublingual bupreno rphine. All doses were administered double-blind. On days 6-13 all pat ients could request a dose change, knowing that their new dose would b e randomly chosen from the remaining 2 alternatives. Compared to place bo, patients given buprenorphine (independent of dose) showed greater time on initial dose, requested fewer dose changes, used less illicit opioids (assessed by urinalysis), and rated dose adequacy higher. Thes e results demonstrate that a placebo controlled study with a behaviora l choice component is an effective means of assessing the potential ef ficacy and acceptability of new pharmacotherapies for opioid dependenc e.