Baclofen in maintenance treatment of opioid dependence: a randomized double-blind clinical trial with placebo-controlled

ABSTRACT

This project was aimed to evaluate the efficacy of baclofen in keeping opioid dependents in maintenance treatment and in reduction of their opioid use. It also assessed its superiority over placebo. In this double blind experimental study, 40 patients with the diagnosis of opioid dependence [DSM- IV based criteria] were inserted randomly in two groups following the detoxification phase. In one group, 20 patients took baclofen [60 mg daily in three divided doses] and in the other one, 20 patients took placebo for a total of 12 weeks. The primary measuring factors included retention of patients in maintenance treatment and positive urine analysis. The project's data were analyzed via statistical Mann-Whitney and chi-square tests. The retention of patients in treatment was significantly more in baclofen group than the placebo group. baclofen group patients exhibited less opioid withdrawal and depressive symptoms than the placebo group. There were no significant differences between the two groups in terms of the rate of positive urine analysis, intensity of craving for opioid use, medication side effects, and the average days of opioid and alcohol consumption during treatment. Baclofen is considerably superior to placebo in keeping the patients in treatment and also in reduction of opioid withdrawal and depressive symptoms