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Randomized Controlled Trial Computer-Base Intervention to Augment Drug Counseling

$320,315R01FY2013DANIH

Duke University, Durham NC

Investigators

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Abstract

DESCRIPTION (provided by applicant): Although interventions using cue exposure for addiction have a sound theoretical rationale and are well grounded in animal learning studies, treatments using this approach have not been well supported. Two particular problems related to exposure- based treatments for addiction are: (1) reliably re-creating conditioned responding and extinguishing cravings to a variety of conditioned stimuli in the therapeutic environment and (2) generalization of extinguished responses to drug-related stimuli in the patient's natural environment. In a previous Stage Ia/b treatment development project (DA-R01- 018311), our group developed and found promising empirical support for the use of a novel computer-based intervention as an adjunct to a manualized and NIDA approved weekly Individual and Group Drug Counseling for cocaine dependence (Combined IDC and GDC; I/GDC; Daley et al., 2003; Mercer & Woody, 1999). Consistent with the mission of Stage II behavioral therapy development (Rounsaville, Carroll, & Onken, 2001), the primary aim of the present application is to follow the earlier Stage Ia/b project by examining the efficacy of a virtual reality-based (VR) cue exposure and cellular phone-based extinction reminder (ER) platform as an adjunctive intervention to I/GDC. Using a treatment manual previously developed that details the rationale and parameters of the VR/ER intervention, we will conduct a Stage II randomized controlled trial in order to rigorously evaluate the efficacy of this novel intervention. Specifically, 180 adult outpatients with crack cocaine dependence will be randomly assigned to receive 6 months of I/GDC alone (weekly individual and group counseling) or I/GDC + VR/ER. In addition to primary analyses examining treatment effects on cocaine use through thrice weekly urinalyses, additional analyses will evaluate differences in retention, other substance use, HIV risk behavior, and mediators/ moderators of treatment outcome across conditions. Comprehensive assessment measures, including measures of physiological and subjective cue reactivity, will be administered at pre-treatment, post- treatment, and 6-month follow-up.

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