Principal Investigator

Allen Zweben, PhD - University of Milwaukee

Co-Investigator

Michael Fleming, MD, MPH - Dept. of Family Medicine

Funding

U.S. Department of Health and Human Services, Public Health Service, < National Institute of Health

Abstract

Recent alcoholism treatment research indicates that both structured psychosocial treatments designed to enhance motivation for abstinence, such as 4-6 sessions of Motivational Enhancement Treatment (MET), provide equivalent and good post-treatment drinking outcomes for alcohol-dependent subjects, when compared with more intensive treatments such as Twelve Step Facilitation. Two medications, naltrexone (NTX), and acamprosate (AC), have been found superior to placebo in prolonging abstinence and reducing post-treatment heavy drinking, when delivered with 12 or more sessions of psychosocial treatment for alcoholism. Given the high expense of more intensive psychosocial treatments, as well as the increasing emphasis on low-intensity intervention in managed care organizations, it is important to determine if good alcoholism treatment outcomes can be acheived by combinations of the medications and moderate- or low-intensity psychosocial treatments for alcohol dependence.

Our research group has had substantial success in conducting pharmacotherapy, MET, and brief intervention studies of alcoholics, including alcoholics who are members of managed-care organizations. We now propose a double-blind, randomized, controlled clinical trial comparing four medication conditions [placebo (PB), NTX, AC, and the combination of NTX and AC], combined in randomized, single-blind fashion with either a moderate intensity psychosocial treatment, MET, or a brief behavioral intervention, Brief MET (BMET), in the treatment of alcohol dependence. BMET is a briefer form of MET that employs only psychoeducational approaches, such as feedbacks, advice, goal formation, and referral to self-help groups and other community resources. Treatment will be provided for six months, with follow-up assessments conducted at the end of active treatment and every three months during the one-year post-treatment follow-up period. We hypothesize that both medications, and their combination, will provide superior outcomes to placebo (PBO) treatment, when combined with either MET or BMET. We also hypothesize that MET and BMET will not significantly differ in effectiveness.

To test the feasibility and efficacy of BMET, a pilot study involving 40 subjects will be conducted for a one-year period preceding the implementation of the main phase of the proposed study. Subject outcomes in both the pilot and main studies will assess several alcohol related domains: percent days abstinent, drinks per drinking day, time (days) to relapse, drinking related problems, biologic indices of heavy drinking (Carbohydrate-Deficient Transferrin and GGT), and compliance with these medications. A cost-effectiveness analysis will be conducted along with these clinical outcome analyses, so that the results will be applicable to managed care organizations, where substantial numbers of alcohol-dependent clients receive health care treatment.