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

Theresa Winhusen, PhD
Lead Investigator

University of Cincinnati/CinARC

The primary objective of this study is to evaluate the efficacy of 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.

CTN-0052 Study Protocol


No significant treatment effects of buspirone on maximum continuous days of cocaine abstinence or days to first cocaine use were found. Additionally, in female participants (n=23), there was a significant treatment-by-time interaction effect, reflecting an increase in cocaine use by those receiving buspiron, relative to placebo, early in the outpatient treatment phase; a similar effect was not detected in males. These results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and, in fact, may worsen outcomes for women in particular.

Primary Outcomes Article: Winhusen TM, et al. Multisite, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Buspirone as a Relapse-Prevention Treatment for Cocaine Dependence. Journal of Clinical Psychiatry 2014;75(7):757-764. [get article]



Publications about CTN-0052

Study data from NIDA Data Share (NCT01641159)

NIDA protocol page

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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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Updated 7/2014 --