The primary objective of this proposal is to establish a clinical Coordinating Center for the Combined Behavioral/Pharmacologic Treatment of Alcoholism Patients (CBPTA) project within the Collaborative Studies Coordinating Center (CSCC) in the Department of Biostatistics at the University of North Carolina at Chapel Hill. The CSCC project team will collaborate in the development of the study protocol, manual of operations, and data collection forms, and provide administrative support for their development. We will take a leadership role in developing procedures for collecting, editing, storing, and analyzing data generated by the clinical Centers. We will develop procedures for eligibility verification and randomization, using an automated touchtone, voice response system. We will provide training to clinical Center staff in study procedures, including data collection and management, through a combination of written manuals and centralized and on-site training. We will design and implement quality control programs for diagnosis, intervention delivery, data collection, and central laboratory determinations. We will provide statistical expertise for study design and analysis and perform all data analysis. We will collaborate in the preparation of scientific publications and presentations. We will provide all necessary support to the Data and Safety Monitoring Board (DSMB), including production of interim analyses, and administrative support for Steering Committee meetings. We will organize and provide administrative support for Steering Committee and subcommittee meetings. We will manage procurement, packaging, and distribution of study medications. We will manage application for any necessary IND approval(s). We will develop appropriate procedures for sample and data transfer and quality control for central laboratory determinations.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10AA011721-04
Application #
6168433
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
2000-09-01
Budget End
2001-08-31
Support Year
4
Fiscal Year
2000
Total Cost
$1,088,470
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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
DiClemente, Carlo C; Doyle, Suzanne R; Donovan, Dennis (2009) Predicting treatment seekers' readiness to change their drinking behavior in the COMBINE Study. Alcohol Clin Exp Res 33:879-92
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
Ernst, Denise B; Pettinati, Helen M; Weiss, Roger D et al. (2008) An intervention for treating alcohol dependence: relating elements of Medical Management to patient outcomes with implications for primary care. Ann Fam Med 6:435-40
Weiss, Roger D; O'malley, Stephanie S; Hosking, James D et al. (2008) Do patients with alcohol dependence respond to placebo? Results from the COMBINE Study. J Stud Alcohol Drugs 69:878-84
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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