The safety of disulfiram for the treatment of alcohol and cocaine dependence in randomized clinical trials: Guidance for clinical practice

Robert Malcolm, Michael Olive, William Lechner

Research output: Contribution to journalArticle

37 Scopus citations


Background: Disulfiram has demonstrated efficacy in six randomized clinical trials for the treatment of cocaine dependence, but is rarely used in clinical settings because of safety concerns. Objective: What are the common and serious side effects of disulfiram in cocaine-dependent individuals with and without alcohol dependence in randomized clinical trials? Methods: We located Phase I and II randomized trials that discussed the safety of disulfiram. Results/conclusions: In randomized clinical trials that eliminated subjects with serious cardiovascular, hepatic, and psychiatric disorders, the most frequent side effects of disulfiram over placebo or index groups include headaches, fatigue, sleepiness, and anxiety. Disulfiram in a dose of ≤ 250 mg/day led to only mild interactions with alcohol. When patients are screened for medical and psychiatric stability, and are evaluated for drug interactions, disulfiram has an acceptable side-effect profile for the treatment of cocaine dependence with or without alcohol dependence.

Original languageEnglish (US)
Pages (from-to)459-472
Number of pages14
JournalExpert Opinion on Drug Safety
Issue number4
Publication statusPublished - Jul 2008
Externally publishedYes



  • Alcohol dependence
  • Cocaine dependence
  • Disulfiram
  • Randomized clinical trials
  • RCTs
  • Safety

ASJC Scopus subject areas

  • Pharmacology

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