Back to resultsDextroamphetamine-Cocaine Behavioral Intervention - 5
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextroamphetamine
D-amphetamine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Please contact site for information.
Sites / Locations
- University of Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
30 mg of d-amphetamine for first 8 weeks of study and 60 mg for the second 8 weeks
placebo
Outcomes
Primary Outcome Measures
Verifiable cocaine abstinence
Secondary Outcome Measures
Full Information
NCT ID
NCT00000308
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00000308
Brief Title
Dextroamphetamine-Cocaine Behavioral Intervention - 5
Official Title
D-amphetamine-Cocaine Behavioral Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
September 2000 (Actual)
Study Completion Date
September 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
30 mg of d-amphetamine for first 8 weeks of study and 60 mg for the second 8 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine
Intervention Description
15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
Intervention Type
Drug
Intervention Name(s)
D-amphetamine
Intervention Description
15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Verifiable cocaine abstinence
Time Frame
16 weeks of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Grabowski, Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dextroamphetamine-Cocaine Behavioral Intervention - 5
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