Nefazodone in out-patient treatment of inhaled cocaine dependence: a randomized double-blind placebo-controlled trial.
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.
Passos
Sonia Regina Lambert
SR
Department of Epidemiology, Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil. sonialambert@ipec.fiocruz.br
Camacho
Luiz Antonio Bastos
LA
Lopes
Claudia S
CS
dos Santos
Maria Angélica Borges
MA
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*
D018687:Antidepressive Agents, Second-Generation; D010879:Piperazines; D014230:Triazoles; C051752:nefazodone