A multi-site, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.

This presentation reports on a National Drug Abuse Treatment Clinical Trials Network (CTN) study that aimed to evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence (CTN-0052). This randomized, double-blind, placebo-controlled, 16-week pilot trials was conducted at 6 clinical sites. Adults meeting DSM-IV-TR criteria for current cocaine dependence scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized, and planning to enroll in local outpatient treatment through the end of the active treatment phase, were randomized to buspirone titrated to 60 mg/day (n=35) or to placebo (n=27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous cocaine abstinence (primary), proportion of cocaine use days, and days-to-first-cocaine-use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens.

Study retention was high, with a 94% completion rate, and medication adherence was also strong (85% based on medication events monitoring system). However, there were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. Additionally, buspirone, relative to placebo, actually increased the proportion of cocaine use days in female participants, though not in males.

Conclusions: These results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and may even worsen cocaine use outcomes for women.

Related protocols: CTN-0052