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Nefazodone in out-patient treatment of inhaled cocaine dependence: a randomized double-blind placebo-controlled trial.

Author(s): Passos SR, Camacho LA, Lopes CS, dos Santos MA

Affiliation(s): Department of Epidemiology, Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil. sonialambert@ipec.fiocruz.br

Publication date & source: 2005-04, Addiction., 100(4):489-94.

Publication type: Clinical Trial; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

AIMS: To assess the efficacy of oral nefazodone in the treatment of cocaine dependence. DESIGN: 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. FINDINGS: 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.

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