CTN-0052: A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults with Cocaine Dependence (BRAC)

T. John Winhusen, PhD
Lead Investigator
University of Cincinnati
Addiction Sciences Division
winhust@ucmail.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.

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]

    Node Involvement

    Lead Node(s):

  • Ohio Valley Node

  • All Participating Nodes:

  • Appalachian Tri-State Node
  • Delaware Valley Node
  • Florida Node Alliance
  • Ohio Valley Node
  • Southern Consortium Node
  • Texas Node