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NIDA-MDS-0003

Division

DTMC

HEAL Study

Investigator(s)

John D. Roache, Ph.D.

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.

Keywords

Assessments

Positive Symptom Rating Scale

Profile of Mood States

Visual Analog Scales

Vital Signs Monitoring