To obtain access to any datasets listed on this site, you must first receive approval from NIDA Datashare's Data Access Committee (DAC).

Please submit your request by sending your request to NIDA_Datashare_DAC@mail.nih.gov along with the following information:

Your name, title, and organization
Study Number and Study Title
The specific dataset(s) you are requesting
The intended use or purpose of the data
Willingness to comply with the NIDA Datashare Registration Agreement

Once your request is reviewed, you will receive instructions on how to proceed.

Thank you for your cooperation.

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