This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Objective: To assess the efficacy of baclofen in reducing cocaine use in subjects with cocaine dependence (DSM-IV criteria). The hypothesis is that baclofen will reduce cocaine use over the treatment period as compared to placebo as determined by self-report confirmed with urine assays for benzoylecgonine, a cocaine metabolite. Study Design: A multi-center, double blind, placebo-controlled, parallel design study funded through the VA Collaborative Center Perry Point, MD with funds allocated from the National Institute of Drug Abuse. There are 8 treatment sites both at Veterans Administration (VA) and non-VA institutions in the United States. Each clinical site will enroll 20 subjects giving the study approximately 160 subjects. This outpatient medication and counseling trial is being conducted at the STVHCS-ALMD Substance Abuse Treatment Program (SATP). Double blind, placebo-controlled, parallel design study in which, after a 14-day screening period, subjects will be randomly assigned to receive baclofen or matched placebo administered orally for 8 weeks with follow-up assessment for 4 weeks after treatment completion. During the screening and treatment periods, subjects will have three study visits per week. Urine samples will be collected 3 times a week for BE and creatinine and the first sample of the week will be additionally analyzed for amphetamines, opiates and benzodiazepines. During the treatment period, the study medication dose will consist of a dose escalation phase (week 1) with baclofen escalating from 10mg to 60mg daily or matched placebo, maximal-dose phase (weeks 2 to 7) with 60mg baclofen daily or matched placebo and a dose taper phase (week 8) with baclofen dose tapering off or matched placebo. Follow-up will consist of assessments and urine collections once each week during weeks 9, 10, 11 and 12. Adaptive randomization will be used to balance treatment groups based on clinical site and gender. All subjects will receive psychosocial therapy that will consist of a weekly session of cognitive behavioral therapy during the 8-week treatment period.
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