Back to resultsInteractions Between Cocaine and Ethanol and Disulfiram - 1
Primary Purpose
Alcohol-Related Disorders, Cocaine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Disulfiram
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol-Related Disorders
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Please contact site for more information.
Sites / Locations
- UCLA Integrated Substance Abuse Program
- University of Texas Hlth Sci Ctr San Ant
Outcomes
Primary Outcome Measures
Safety assessments
Psychological effects
Secondary Outcome Measures
Full Information
NCT ID
NCT00094289
First Posted
October 15, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00094289
Brief Title
Interactions Between Cocaine and Ethanol and Disulfiram - 1
Official Title
Interactions Between IV Cocaine and Ethanol and Oral Disulfiram
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.
Detailed Description
This is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Cocaine-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Disulfiram
Primary Outcome Measure Information:
Title
Safety assessments
Title
Psychological effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Please contact site for more information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Roache, Ph.D.
Organizational Affiliation
University of Texas Health Sci Cntr, San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Texas Hlth Sci Ctr San Ant
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284 7828
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interactions Between Cocaine and Ethanol and Disulfiram - 1
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