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

Authors

  • Sonia Regina Lambert Passos,

    Corresponding author
    1. Department of Epidemiology, Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation
      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: sonialambert@ipec.fiocruz.br
    Search for more papers by this author
  • Luiz Antonio Bastos Camacho,

    1. Department of Epidemiology and Quantitative Methods, Brazilian National School of Public Health, Oswaldo Cruz Foundation
    Search for more papers by this author
  • Claudia S. Lopes,

    1. Social Medicine Institute of State University of Rio de Janeiro
    Search for more papers by this author
  • Maria Angélica Borges dos Santos

    1. Brazilian Health Ministry, Rio de Janeiro, Brazil
    Search for more papers by this author

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: sonialambert@ipec.fiocruz.br

ABSTRACT

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.

Ancillary