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 beer found superior to placebo in prolonging abstinence and reducing posttreatment heavy drinking, when delivered 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 achieved by combinations of these 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 (PBO), NTX, AC, and the combination of NT) 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 its feedback, 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 their 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 modifications. 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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10AA011773-06
Application #
6533591
Study Section
Special Emphasis Panel (ZAA1-EE (01))
Program Officer
Litten, Raye Z
Project Start
1997-09-30
Project End
2003-08-31
Budget Start
2002-09-01
Budget End
2003-08-31
Support Year
6
Fiscal Year
2002
Total Cost
$393,717
Indirect Cost
Name
University of Wisconsin Milwaukee
Department
Type
Schools of Social Work
DUNS #
City
Milwaukee
State
WI
Country
United States
Zip Code
53201
Doyle, Suzanne R; Donovan, Dennis M; Simpson, Tracy L (2011) Validation of a nine-dimensional measure of drinking motives for use in clinical applications: the desired effects of drinking scale. Addict Behav 36:1052-60
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Doyle, Suzanne R; Donovan, Dennis M (2009) A validation study of the alcohol dependence scale. J Stud Alcohol Drugs 70:689-99
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Anton, Raymond F; Oroszi, Gabor; O'Malley, Stephanie et al. (2008) An evaluation of mu-opioid receptor (OPRM1) as a predictor of naltrexone response in the treatment of alcohol dependence: results from the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study. Arch Gen Psychiatry 65:135-44
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Doyle, Suzanne R; Donovan, Dennis M; Kivlahan, Daniel R (2007) The factor structure of the Alcohol Use Disorders Identification Test (AUDIT). J Stud Alcohol Drugs 68:474-9
Donovan, Dennis M; Kivlahan, Daniel R; Doyle, Suzanne R et al. (2006) Concurrent validity of the Alcohol Use Disorders Identification Test (AUDIT) and AUDIT zones in defining levels of severity among out-patients with alcohol dependence in the COMBINE study. Addiction 101:1696-704
Anton, Raymond F; Youngblood, Marston (2006) Factors affecting %CDT status at entry into a multisite clinical treatment trial: experience from the COMBINE Study. Alcohol Clin Exp Res 30:1878-83

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