Veterans Administration cooperative study of disulfiram in the treatment of alcoholism: study design and methodological considerations.

Disulfiram treatment of alcoholism has been difficult to evaluate in controlled studies because the study design must contend with problems unique to this drug. The therapeutic effect may be a result of the patient's fear of the disulfiram-ethanol reaction rather than a direct pharmacological effect on the craving for alcohol. Good outcome may not be directly related to compliance with the drug regimen; a patient may remain abstinent even if he does not take his medication. The Veterans Administration Cooperative Study "Disulfiram in the Treatment of Alcoholism," is a multicenter, randomized, blinded, controlled clinical trial designed to evaluate the efficacy of disulfiram while addressing these issues. Two control groups are used. The members of one control group will not receive disulfiram and will be told they are not receiving disulfiram. The members of the other control group will be given disulfiram and will be told they are receiving disulfiram; however, the dose of their disulfiram will be measured by doing pill counts and obtaining urine specimens at each clinic visit and measuring urinary diethylamine, a metabolite of disulfiram, and riboflavin (a medication marker).

RCT Entities:   Population Interventions Outcomes