Back to resultsOndansetron for the Treatment of Cocaine Dependence - 1
Primary Purpose
Cocaine-Related Disorders, Drug Administration Schedule
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria: Male/Female, at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; seeking Treatment for cocaine dependence; have ability to understand, having understood and provide written consent; females of child bearing potential that use accepted method of birth control Exclusion Criteria: Additional criteria available during screening at the site.
Sites / Locations
- University of Texas Hlth Sci Ctr San Ant
Outcomes
Primary Outcome Measures
Cocaine use
Secondary Outcome Measures
Full Information
NCT ID
NCT00033085
First Posted
April 5, 2002
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00033085
Brief Title
Ondansetron for the Treatment of Cocaine Dependence - 1
Official Title
Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of ondansetron to reduce cocaine use in subjects with cocaine dependence.
Detailed Description
Double-blind, placebo-controlled, 4-parallel group design to assess the efficacy and safety of 3 wide range doses of ondansetron to reduce cocaine use in subjects with cocaine dependence and to determine the optimal dose of ondansetron.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Drug Administration Schedule
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Primary Outcome Measure Information:
Title
Cocaine use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male/Female, at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; seeking Treatment for cocaine dependence; have ability to understand, having understood and provide written consent; females of child bearing potential that use accepted method of birth control
Exclusion Criteria:
Additional criteria available during screening at the site.
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 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
Ondansetron for the Treatment of Cocaine Dependence - 1
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