PROTOCOL NIDA-CTN-0052


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

Theresa Winhusen, PhD
Lead Investigator

University of Cincinnati/CinARC
winhusen@carc.uc.edu

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

PRIMARY FINDINGS

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]

RELATED RESOURCES

snowflake

Publications about CTN-0052

ClinicalTrials.gov (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.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 7/2014 -- http://ctndisseminationlibrary.org/protocols/ctn0052.htm
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