Back to resultsDevelopment of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1
Primary Purpose
Cocaine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cocaine (IV)
Sponsored by
About this trial
This is an interventional trial for Cocaine-Related Disorders
Eligibility Criteria
Inclusion Criteria: Be English-speaking volunteers who are cocaine dependent Be non-treatment seeking at the time of the study Meet DSM-IV criteria for cocaine dependence Have ECG showing normal sinus rhythm, normal conductivity, and non clinically significant arrhythmias Females must provide a negative pregnancy test and agree to use birth control Have baseline laboratory tests within normal limits Exclusion Criteria: Please contact site for more information
Sites / Locations
- University of Texas Health Science Center
Outcomes
Primary Outcome Measures
Stimulated and non-stimulated craving
Cocaine assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00094315
First Posted
October 15, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00094315
Brief Title
Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1
Official Title
Cocaine Relapse Prevention II
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 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
To study of classical conditioning mechanisms associated with arousal, craving and cocaine use.
Detailed Description
This is a single-site, double-blind, placebo-controlled crossover study of classical conditioning mechanisms associated with arousal, craving and cocaine use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
7. Study Design
Study Phase
Phase 1
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cocaine (IV)
Primary Outcome Measure Information:
Title
Stimulated and non-stimulated craving
Title
Cocaine assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be English-speaking volunteers who are cocaine dependent
Be non-treatment seeking at the time of the study
Meet DSM-IV criteria for cocaine dependence
Have ECG showing normal sinus rhythm, normal conductivity, and non clinically significant arrhythmias
Females must provide a negative pregnancy test and agree to use birth control
Have baseline laboratory tests within normal limits
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1
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