Expert Opinion on Drug Safety 2008-Jul
The safety of disulfiram for the treatment of alcohol and cocaine dependence in randomized clinical trials: guidance for clinical practice.
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Abstract
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.
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
