Back to resultsA Study of Cabergoline for the Treatment of Cocaine Dependence - 1
Primary Purpose
Cocaine-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cabergoline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility Criteria
Inclusion Criteria: Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control. Exclusion Criteria: Additional criteria available during screening at the site.
Sites / Locations
- Torrance Clinic
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cabergoline
Placebo
Arm Description
Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.
Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.
Outcomes
Primary Outcome Measures
To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence
Success in the reduction of cocaine use was determined by comparing cocaine non-use days (self-report confirmed or disproved by urine BE level at each study visit) expressed as the weekly mean proportion of non-use days to the total number of non-missing study days that week.
Secondary Outcome Measures
Reduction in cocaine use
Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels
Full Information
NCT ID
NCT00033111
First Posted
April 5, 2002
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT00033111
Brief Title
A Study of Cabergoline for the Treatment of Cocaine Dependence - 1
Official Title
Phase 2, Double-Blind, Placebo Controlled Trial of Cabergoline for the Treatment of Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
Detailed Description
To assess the efficacy and safety of cabergoline in reducing cocaine use in subjects with cocaine dependence. This is a DB, placebo-controlled, parallel group design study where subjects will receive either .5mg cabergoline or placebo for 12 weeks with a 4 week follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Substance-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabergoline
Arm Type
Active Comparator
Arm Description
Subjects received one tablet of 0.5 mg of cabergoline tablet per week for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received one tablet of 0.5 mg of cabergoline matched placebo tablet per week for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
Dostinex
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sugar pill manufactured to mimic cabergoline 05mg tablet
Primary Outcome Measure Information:
Title
To assess the efficacy of cabergoline in reducing cocaine use in subjects with cocaine dependence
Description
Success in the reduction of cocaine use was determined by comparing cocaine non-use days (self-report confirmed or disproved by urine BE level at each study visit) expressed as the weekly mean proportion of non-use days to the total number of non-missing study days that week.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Reduction in cocaine use
Description
Measured by the weekly mean proportion of non-use days according to the subject's self report without regard to BE levels
Time Frame
12 weeks
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:
Must have a DSM-4 criteria for cocaine dependence; be seeking treatment for cocaine dependence; have the ability to understand and provide written informed consent; females of child-bearing potential using proper method of birth control.
Exclusion Criteria:
Additional criteria available during screening at the site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Shoptaw, Ph.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Torrance Clinic
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Cabergoline for the Treatment of Cocaine Dependence - 1
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