title: Nefazodone in out-patient treatment of inhaled cocaine dependence: a randomized double-blind placebo-controlled trial.
abstract: OBJECTIVE
  To assess the efficacy of oral nefazodone in the treatment of cocaine dependence.
  
  
  METHODS
  A 10-week randomized double-blind clinical trial was performed.
  
  
  METHODS
  All 210 subjects fulfilled Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence and were assigned randomly to 300 mg/day of oral nefazodone (N) or placebo (P). Self-reported drug use, retention interval in treatment, adherence to prescription and depressive symptoms were assessed by the Hamilton scale.
  
  
  RESULTS
  Abstinence from cocaine for 3 weeks or more was achieved by 49.5% (N) and 45.7% (P) (P = 0.58), but 16.2% (N) and 22.9% (P) used other drugs during abstinence. The average interval to resumption of drug use was 33.9 days (N) and 36.1 days (P). Adverse effects were reported by 45.8% (N) and 29.5% (P) (P = 0.01). Treatment for these events was needed more often in N (24.0%) than in P (9.5%) (P < 0.02).
  
  
  CONCLUSIONS
  These results do not support the indication of nefazodone for out-patient treatment of inhaled cocaine dependence with or without other associated drug dependence diagnoses.
authors.affiliation: Department of Epidemiology, Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil. sonialambert@ipec.fiocruz.br
authors.forename: Sonia Regina Lambert
authors.initials: SR
authors.lastname: Passos
authors.forename: Luiz Antonio Bastos
authors.initials: LA
authors.lastname: Camacho
authors.forename: Claudia S
authors.initials: CS
authors.lastname: Lopes
authors.forename: Maria Angélica Borges
authors.initials: MA
authors.lastname: dos Santos
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000534:rehabilitation*; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D010879:Piperazines; D014230:Triazoles / Q000627:therapeutic use*
chemical_list: D018687:Antidepressive Agents, Second-Generation; D010879:Piperazines; D014230:Triazoles; C051752:nefazodone