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


Sonia Regina Lambert Passos, Instituto de Pesquisa Clínica Evandro  Chagas—Fundação Oswaldo Cruz, Epidemiology Department, Avenue Brasil 4365, Manguinhos, Rio de Janeiro, Brazil CEP: 21045–900, Tel: 55 21 3286 9544, Fax: 55 21 22609749, e.mail:


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.