title: Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.
abstract: OBJECTIVE
  To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  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 (χ²₁ = 15.26, P < .0001), 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; χ²₁ = 0.14, P = .70).
  
  
  CONCLUSIONS
  The 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 worsen their cocaine use outcomes.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01641159.
authors.affiliation: University of Cincinnati, Department of Psychiatry, 3131 Harvey Ave, Cincinnati, OH 45229 winhust@uc.edu.
authors.forename: Theresa M
authors.initials: TM
authors.lastname: Winhusen
authors.forename: Frankie
authors.initials: F
authors.lastname: Kropp
authors.forename: Robert
authors.initials: R
authors.lastname: Lindblad
authors.forename: Antoine
authors.initials: A
authors.lastname: Douaihy
authors.forename: Louise
authors.initials: L
authors.lastname: Haynes
authors.forename: Candace
authors.initials: C
authors.lastname: Hodgkins
authors.forename: Karen
authors.initials: K
authors.lastname: Chartier
authors.forename: Kyle M
authors.initials: KM
authors.lastname: Kampman
authors.forename: Gaurav
authors.initials: G
authors.lastname: Sharma
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Lewis
authors.forename: Paul
authors.initials: P
authors.lastname: VanVeldhuisen
authors.forename: Jeff
authors.initials: J
authors.lastname: Theobald
authors.forename: Jeanine
authors.initials: J
authors.lastname: May
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Brigham
mesh_terms: D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002065:Buspirone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D055502:Secondary Prevention; D012737:Sex Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014151:Anti-Anxiety Agents; D002065:Buspirone