TSF to enhance treatment of cocaine dependence

$305,411P50FY2000DANIH

Yale University, New Haven CT

Investigators

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Abstract

Cocaine use remains epidemic among most methadone maintenance programs and is associated with a host of concurrent problems, particularly higher risk of intravenous drug use and HIV. Disulfiram is a promising treatment for cocaine abuse in this setting, but this effect must be replicated with a larger sample. Moreover, it is critical to evaluate whether disulfiram's effectiveness can be enhanced though adding a more potent psychotherapeutic approach. Manualized Twelve-Step Facilitation (TSF) is a promising but understudied psychotherapeutic approach worthy of extended empirical evaluation. The proposed 2X2 design will permit evaluation of TSF as adjunct to standard methadone maintenance as well as its benefits in combination with disulfiram. In this Stage II study, 180 cocaine-dependent methadone-maintained opioid addicts will be assigned, using urn randomization, to one of four treatments: (1) Twelve-Step Facilitation (TSF) in addition to standard methadone counseling plus disulfiram, (2) Twelve-Step Facilitation (TSF) plus placebo, (3) Standard methadone counseling plus disulfiram, or (4) Standard methadone counseling plus placebo. Study treatments will be manual-guided and will last 12 weeks. The primary outcome will be reduction in cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalysis. Second outcomes will include reductions in illicit opioid and alcohol use, as well as improvements in psychosocial functioning. Treatments will be delivered by experienced clinicians, who will receive training and ongoing supervision to prevent drift during the course of the study. Supervised urines will be collected thrice weekly. All counseling sessions will be videotaped for ongoing therapist supervision and process assessment. Follow-ups at 1,3, 6, 9 and 12 months after cessation of study treatments will assess the durability and/or delayed emergence of treatment effects.

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