NCT00094289

Brief Summary

The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

October 15, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

January 11, 2017

Status Verified

July 1, 2005

First QC Date

October 15, 2004

Last Update Submit

January 10, 2017

Conditions

Alcohol-Related DisordersCocaine-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • Safety assessments

  • Psychological effects

Interventions

DisulfiramDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must meet DSM-4 criteria for cocaine abuse or dependence and are not seeking treatment.
  • Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements.

You may not qualify if:

  • Please contact site for more information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Integrated Substance Abuse Program

Los Angeles, California, 90024, United States

Location

University of Texas Hlth Sci Ctr San Ant

San Antonio, Texas, 78284 7828, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersCocaine-Related Disorders

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DitiocarbThiocarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsDisulfidesSulfidesSulfur Compounds

Study Officials

  • John Roache, Ph.D.

    University of Texas Health Sci Cntr, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 15, 2004

First Posted

October 15, 2004

Study Start

August 1, 2004

Study Completion

July 1, 2005

Last Updated

January 11, 2017

Record last verified: 2005-07

Locations

US(2)