Back to resultsDextroamphetamine as an Adjunct in Cocaine Treatment - 1
Primary Purpose
Cocaine-Related Disorders, Substance-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
15/30 mg d-amphetamine
30/60 mg d-amphetamine
placebo
Outcomes
Primary Outcome Measures
verifiable cocaine abstinence
Secondary Outcome Measures
Full Information
NCT ID
NCT00000304
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
NCT00000304
Brief Title
Dextroamphetamine as an Adjunct in Cocaine Treatment - 1
Official Title
Dextroamphetamine as an Adjunct in Cocaine Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
August 2001 (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 evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.
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
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
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
15/30 mg d-amphetamine
Arm Title
2
Arm Type
Experimental
Arm Description
30/60 mg d-amphetamine
Arm Title
3
Arm Type
Experimental
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine
Intervention Description
15 mg for first 8 weeks and 30 mg for 2nd 8 weeks
Intervention Type
Drug
Intervention Name(s)
D-Amphetamine
Intervention Description
30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total)
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 as an Adjunct in Cocaine Treatment - 1
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