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

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 <or= 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.