The University of New Mexico's Center on Alcoholism, Substance Abuse, and Addictions (CASAA) offers to participate as a Clinical Research Unit (CRU) in the multisite trial, Combined Behavioral/Pharmacological Treatment of Alcoholism. Although the trial protocol will ultimately be determined by the trial's Steering Committee, this proposal reflects how CASAA might approach the project. Our factorial design for the main (Phase M) trial crosses four levels of medication (placebo, acamprosate, naltrexone, and combined medications) with two levels of behavioral intervention (Cognitive-Behavioral Therapy and Motivational Enhancement Therapy), both modified from manuals and experience in Project MATCH. Following the initial treatment period (months 1-3), clients are assigned at random to receive or not receive augmented treatment during months 4-6. This embedded trial will provide reliable information about main effects of longer (augmented) versus shorter treatment, and about client characteristics associated with differential benefit from augmented treatment. Augmentation will be retained within each behavioral treatment modality, so as not to confound the interpretableness of follow-up data. The prospective validity of various 'nonresponder' classification systems can be tested via retrospective analyses within this design. In addition to feasibility testing of procedures, the preliminary (Phase II) study will evaluate the main effect of extensive pretreatment and follow-up assessment on treatment outcomes, a crucial issue because such reactivity could wash out main or interaction effects of trial treatments - a critique unaddressed in Project MATCH. Clients in the Phase II study will all be given the both acamprosate and naltrexone, and further randomized within a 2x2 factorial design to receive either extensive or minimal assessment, and, either CBT or MET. The Phase II study design also allows evaluation of whether a client's knowledge that drinking reports will be verified via collateral interviews affects the accuracy of self-reports. Main trial clients will be randomly assigned to therapists within conditions, so that (unlike in Project MATCH), true tests of client/therapist matches can be conducted in this large sample. Prior to randomization, all clients will be challenged with an initial medication dose (which exerts immediate aversive effects in a minority of individuals), to diminish potentially problematic differential attrition from medication and placebo groups. Naturalistic involvement in Alcoholics Anonymous and other mutual help organizations will be studied to determine whether it interacts with these treatments to enhance outcomes.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10AA011716-05
Application #
6371456
Study Section
Special Emphasis Panel (ZAA1-EE (01))
Program Officer
Fuller, Richard K
Project Start
1997-09-30
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2002-08-31
Support Year
5
Fiscal Year
2001
Total Cost
$393,577
Indirect Cost
Name
University of New Mexico
Department
Psychology
Type
Schools of Arts and Sciences
DUNS #
829868723
City
Albuquerque
State
NM
Country
United States
Zip Code
87131
Houck, Jon M; Manuel, Jennifer K; Moyers, Theresa B (2018) Short- and Long-Term Effects of Within-Session Client Speech on Drinking Outcomes in the COMBINE Study. J Stud Alcohol Drugs 79:217-222
Moyers, Theresa B; Houck, Jon; Rice, Samara L et al. (2016) Therapist empathy, combined behavioral intervention, and alcohol outcomes in the COMBINE research project. J Consult Clin Psychol 84:221-9
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
Oroszi, Gabor; Anton, Raymond F; O'Malley, Stephanie et al. (2009) OPRM1 Asn40Asp predicts response to naltrexone treatment: a haplotype-based approach. Alcohol Clin Exp Res 33:383-93
Doyle, Suzanne R; Donovan, Dennis M (2009) A validation study of the alcohol dependence scale. J Stud Alcohol Drugs 70:689-99
Ray, Lara A; Oslin, David W (2009) Naltrexone for the treatment of alcohol dependence among African Americans: results from the COMBINE Study. Drug Alcohol Depend 105:256-8
Bogenschutz, Michael P; Scott Tonigan, J; Pettinati, Helen M (2009) Effects of alcoholism typology on response to naltrexone in the COMBINE study. Alcohol Clin Exp Res 33:10-8
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
Donovan, Dennis M; Anton, Raymond F; Miller, William R et al. (2008) Combined pharmacotherapies and behavioral interventions for alcohol dependence (The COMBINE Study): examination of posttreatment drinking outcomes. J Stud Alcohol Drugs 69:5-13
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

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