Disulfiram Treatment of Alcoholism

P to the completion of this well­designed scientific study, which was conducted at nine Veterans Administration Medical Centers, the medication disulfiram (Antabuse®) was controversial in the treatment of alcoholism. The controversy over its efficacy was rooted in the lack of sophisticated scientific data on which to base its effectiveness. Fuller and colleagues used state­of­the­art clinical research methods to design and conduct a study that could answer the question of disulfiram’s efficacy beyond a reasonable doubt. The study reported in this article not only provided answers to impor­ tant questions regarding the use of disulfiram in alcoholism treatment but also defined the methodology for con­ ducting this type of research. It has served as a model for testing the use­ fulness of medication treatment of al­ coholism for the past 10 years. For instance, Fuller and colleagues gave much attention to patient selection cri­ teria; the use of placebo (i.e., inactive) pills for comparison; validation of pa­ tient self­reports of drinking, both with the use of reports from cohabit­ ing friends or relatives (collaborative sources) and biological measure­ ments; and medication compliance markers in the urine. In addition, Fuller and colleagues also emphasized new statistical methods (i.e., survival analysis, which utilizes the time it takes to relapse to alcohol use as the primary unit of analysis), which have been used successfully in other branch­ es of health care research, into the al­ coholism treatment research arena. In this year­long study, 605 male veterans were assigned at random to three medication treatment groups: active disulfiram (i.e., 250­milligram dose), inactive disulfiram (i.e., 1­ milligram dose), and placebo (i.e., no dose). Patients were expected to attend supportive counseling ses­ sions during the course of the study and were encouraged, but not man­ dated, to attend Alcoholics Anony­ mous meetings as well. Each patient and his collaborative source were questioned periodically during the study about the patient’s alcohol consumption and social well­being. The interviewers were unaware of the patient’s medication group assignment. Fuller and colleagues used this information to calcu­ late abstinence rates and the time elapsed prior to a return to drinking for subjects in the three medication treatment groups. Fuller and colleagues sum up their main finding as follows: