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Multisite, Randomized, Double-Blind, Placebo-Controlled Pilot 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. [doi: 10.4088/JCP.13m08862]

Theresa M. Winhusen, PhD (University of Cincinnati, OV Node), Frankie B. Kropp, MS (University of Cincinnati, OV Node), Robert Lindblad, MD (EMMES Corporation, Clinical Coordinating Center), Antoine B. Douaihy, MD (Western Psychiatric Institute and Clinica, AT Node), Louise F. Haynes, MSW (Medical University of South Carolina, SC Node), Candace Hodgkins, PhD (Gateway Community Services, Inc., FNA Node), Karen Chartier, PhD (Nexus Recovery Center, Inc., TX Node), Kyle M. Kampman, MD (University of Pennsylvania Treatment Research Center, DV Node), Gaurav Sharma, PhD (EMMES Corporation, Clinical Coordinating Center), Daniel F. Lewis (University of Cincinnati, OV Node), Paul C. VanVeldhuisen, PhD (EMMES Corporation, Clinical Coordinating Center), Jeff Theobald (University of Cincinnati, OV Node), Jeanine May, PhD (EMMES Corporation, Clinical Coordinating Center), Gregory S. Brigham, PhD (University of Cincinnati, OV Node).

This is the Primary Outcomes Article for CTN-0052. The purpose of this study was to evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. This randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack cocaine users meeting DSM-IV-TR criteria for current cocaine dependence who were 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/d (n=35) or 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.

There were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use. In the female participants (n=23), there was a significant treatment-by-time interaction effect, reflecting an increase in cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n=39).

Conclusions: These results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may, in fact, worsen their cocaine use outcomes. The results from this pilot trial do not provide a strong rationale for conducting a larger follow-up trial as originally planned. (Article (Peer-Reviewed), PDF, English, 2014)

Keywords: Buspirone | Cocaine | Crack cocaine | CTN primary outcomes | Gender differences | Pharmacological therapy | Relapse prevention | Women | Journal of Clinical Psychiatry (journal)

Document No: 1043, PMID: 24911028, PMCID: PMC4125613.

Submitted by CTN Dissemination Librarians, 6/17/2014.


Brigham, Gregory S. mail
Chartier, Karen
Douaihy, Antoine B. mail
Haynes, Louise F. mail
Hodgkins, Candace mail
Kampman, Kyle M. search mail
Kropp, Frankie B. mail
Lewis, Daniel F. mail
Lindblad, Robert search mail
May, Jeanine mail
Sharma, Gaurav mail
Theobald, Jeff mail
VanVeldhuisen, Paul C. mail
Winhusen, Theresa M. mail
NIDA-CTN-0052 www
Ohio Valley (Lead) www
Appalachian Tri-State www
Delaware Valley www
Florida Node Alliance www
Southern Consortium www
Texas www

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