This application is a response to the RFA, 'Combined Behavioral/Pharmacologic Treatment of Alcoholism. Although new medications are being introduced to decrease alcohol intake in alcoholics, little is known about how these medications actually change patterns of alcohol intake and quality of life, what patient profile can best benefit from these medications and what psychotherapies will ultimately optimize treatment outcome.
The specific aim of this proposal is to implement the protocol described in the RFA to examine 1) the main effects of medication-psychotherapy combinations on patient outcomes and 2) the variables hypothesized to moderate patient outcome. In the proposed randomized clinical trial, two psychotherapies differing in treatment intensity and scope, Broad Spectrum therapy (BST) and Motivational Enhancement therapy will be combined with four medication conditions; Naltrexone (NTX), Acamprosate (ACA), NTX+ACA, and Placebo. Patients are treated for six months and response to treatment is followed for an additional one year. Primary outcome domains measured are 1) abstinence and g and 2) psychosocial functioning. Also included in this proposal are two pilot studies designed to address key questions regarding the implementation of the proposed RFA protocol. Pilot 1 will develop an instrument from large existing data sets to measure patient psychosocial resources. Pilot 2 is a randomized six month treatment trial of NTX plus ACA vs. placebo in alcoholics also receiving BST. Overall, we anticipate that the optimum treatment package will be one that targets the most significant of a patients psychosocial needs while addressing the biological aspects of alcohol dependence via effective medication management. In order to address the main study requirements, the proposed pilot investigation addresses three aims: assessing the effects of combined acamprosate and naltrexone administration, pilot testing and refinement of BST, and development of a robust yet parsimonious measure of patient psychosocial resources.
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