title: A placebo-controlled screening trial of tiagabine, sertraline and donepezil as cocaine dependence treatments.
abstract: OBJECTIVE
  To conduct a preliminary evaluation of the safety and efficacy of tiagabine, sertraline or donepezil versus an unmatched placebo control as a treatment for cocaine dependence.
  
  
  METHODS
  A 10-week out-patient study was conducted using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design.
  
  
  METHODS
  This study was conducted at the Cincinnati Medication Development Research Unit (MDRU) and at an affiliated site in Dayton, Ohio.
  
  
  METHODS
  Participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence. Sixty-seven participants were enrolled with 55 completing final study measures.
  
  
  METHODS
  The targeted daily doses of medication were tiagabine 20 mg, sertraline 100 mg and donepezil 10 mg. All participants received 1 hour of manualized individual cognitive behavioral therapy on a weekly basis.
  
  
  METHODS
  Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression Scale-Observer and self-report of cocaine use. Safety measures included adverse events, ECGs, vital signs and laboratory tests.
  
  
  RESULTS
  Subjective measures of cocaine dependence indicated significant improvement for all study groups. Generalized estimating equations analysis indicated that the tiagabine group showed a trend toward a significant decrease in urine BE level from baseline to weeks 5-8 (P = 0.10) and non-significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures.
  
  
  CONCLUSIONS
  The present findings suggest that tiagabine may be worthy of further study as a cocaine dependence treatment.
authors.affiliation: Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH, USA. winhusen@mdru.uc.edu
authors.forename: Theresa M
authors.initials: TM
authors.lastname: Winhusen
authors.forename: Eugene C
authors.initials: EC
authors.lastname: Somoza
authors.forename: Judy M
authors.initials: JM
authors.lastname: Harrer
authors.forename: Juris P
authors.initials: JP
authors.lastname: Mezinskis
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Montgomery
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Goldsmith
authors.forename: Florence S
authors.initials: FS
authors.lastname: Coleman
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Bloch
authors.forename: Deborah B
authors.initials: DB
authors.lastname: Leiderman
authors.forename: Bonita M
authors.initials: BM
authors.lastname: Singal
authors.forename: Paul
authors.initials: P
authors.lastname: Berger
authors.forename: Ahmed
authors.initials: A
authors.lastname: Elkashef
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000534:rehabilitation*; D000077265:Donepezil; D005260:Female; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009557:Nipecotic Acids / Q000627:therapeutic use*; D010880:Piperidines / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D020280:Sertraline / Q000627:therapeutic use*; D000078308:Tiagabine
chemical_list: D000927:Anticonvulsants; D000077265:Donepezil; D007189:Indans; D009557:Nipecotic Acids; D010880:Piperidines; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline; D000078308:Tiagabine