title: A double-blind, placebo-controlled trial of reserpine for the treatment of cocaine dependence.
abstract: BACKGROUND
  Cocaine's increase of dopamine is strongly associated with its reinforcing properties and, thus, agents that reduce dopamine have received much attention as candidate cocaine-dependence treatments. The potential efficacy of reserpine, a dopamine depletor, for treating cocaine dependence is suggested by both pre-clinical research and a small clinical trial.
  
  
  METHODS
  One hundred and nineteen participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double-blind, placebo-controlled outpatient trial. Participants received either reserpine (0.5 mg/day) or matching placebo. All participants received 1h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included cocaine use as determined by self-report confirmed with urine benzoylecgonine results, cocaine craving, addiction severity index scores, and clinical global impression scores. Safety measures included adverse events, EKGs, vital signs, laboratory tests, and the Hamilton Depression Inventory.
  
  
  RESULTS
  Seventy-nine participants (i.e., 66%) completed the 12-week trial. The safety results suggest that reserpine was safe and well tolerated by the participants. The efficacy measures indicated no significant differences between reserpine and placebo.
  
  
  CONCLUSIONS
  These results do not support the efficacy of reserpine as a cocaine-dependence treatment.
authors.affiliation: Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA. winhusen@mdru.uc.edu
authors.forename: Theresa
authors.initials: T
authors.lastname: Winhusen
authors.forename: Eugene
authors.initials: E
authors.lastname: Somoza
authors.forename: Ofra
authors.initials: O
authors.lastname: Sarid-Segal
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Goldsmith
authors.forename: Judy M
authors.initials: JM
authors.lastname: Harrer
authors.forename: Florence S
authors.initials: FS
authors.lastname: Coleman
authors.forename: Roberta
authors.initials: R
authors.lastname: Kahn
authors.forename: Sabuhi
authors.initials: S
authors.lastname: Osman
authors.forename: Juris
authors.initials: J
authors.lastname: Mezinskis
authors.forename: Shou-Hua
authors.initials: SH
authors.lastname: Li
authors.forename: Daniel
authors.initials: D
authors.lastname: Lewis
authors.forename: Maryam
authors.initials: M
authors.lastname: Afshar
authors.forename: Domenic A
authors.initials: DA
authors.lastname: Ciraulo
authors.forename: Paul
authors.initials: P
authors.lastname: Horn
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Montgomery
authors.forename: Ahmed
authors.initials: A
authors.lastname: Elkashef
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use; D001521:Behavior Therapy; D003042:Cocaine / Q000008:administration & dosage; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000523:psychology*; D003071:Cognition; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012110:Reserpine / Q000627:therapeutic use*; D012907:Smoking
chemical_list: D014150:Antipsychotic Agents; D010919:Placebos; D012110:Reserpine; D003042:Cocaine