NCT01641159

Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence

A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence (BRAC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether or not buspirone is effective in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge.

Detailed description

The primary objective is to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge. Secondary objectives include evaluating the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone's efficacy as a relapse-prevention treatment.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Buspirone	Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
DRUG	Placebo	Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-07-16
• Last updated: 2015-01-07
• Results posted: 2014-12-17

Locations

6 sites across 1 country: United States