NIDA-MDS-0003

Division
HEAL Study
Investigator(s)
Title
Phase I, Double-Blind, Placebo-Controlled Assessment Of Potential Interactions Between Intravenous Cocaine And Ethanol And Oral Disulfiram
Short Description
The primary outcome measures to address the safety of disulfiram treatment are adverse events, changes in cardiac (ECG) and cardiovascular responses (HR, BP) and observations of significant negative psychiatric effects (mPSRS, as well as POMS and self-rated DER) from disulfiram, ethanol and cocaine.
Release Date
Dec 21, 2017
Description

The primary study objective is to assess the safety of disulfiram as a putative cocaine treatment agent by increasing our understanding of how disulfiram alters the cocaine response and how the addition of small doses of ethanol may alter this cocaine response. Satisfaction of this objective is required before the FDA will consider approval of further clinical trials with disulfiram treatment for cocaine dependence.

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Study Data
Study Links
Study Documents
Case Report Form(s)
Deidentification Notes