NIDA-CSP-1019

Division
HEAL Study
Title
Double-Blind, Placebo-Controlled Trial Of Selegiline Transdermal System For The Treatment Of Cocaine Dependence
Short Description
To assess the efficacy and safety of the Selegiline Transdermal System (STS) in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that selegiline treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
Release Date
May 07, 2018
Description

The primary objective of this randomized controlled trial is the assessment of the efficacy of STS in reducing cocaine use in subjects with cocaine dependence (DSM-IV criteria). The hypothesis is that STS will reduce the weekly mean proportion of cocaine non-use days relative to placebo as determined by self report of use confirmed with urine assays for BE.  Secondary objectives include assessing the reduction in the overall proportion of non-use days and the proportion of subjects that achieve measured reductions in cocaine and other drugs use, the reduction in the severity of cocaine dependence and craving, and severity of depression (HAM-D), and the safety of STS in the study population.

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