Back to resultsA Pilot Trial of Dextroamphetamine for Methamphetamine Dependence (1D)
Primary Purpose
Methamphetamine Addiction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextroamphetamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Methamphetamine Addiction focused on measuring Methamphetamine, Drug Abuse, Drug Treatment, Addiction, Meth, Treatment for Methamphetamine Dependence
Eligibility Criteria
Inclusion Criteria:
- 18-50 yrs. old
Exclusion Criteria:
pregnant or lactating females
- Contact site for additional information
Sites / Locations
- CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dextroamphetamine
Placebo
Arm Description
Active drug
Placebo of drug
Outcomes
Primary Outcome Measures
Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)
Secondary Outcome Measures
Full Information
NCT ID
NCT00630682
First Posted
February 28, 2008
Last Updated
May 30, 2013
Sponsor
California Pacific Medical Center Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00630682
Brief Title
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
Acronym
1D
Official Title
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Pacific Medical Center Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methamphetamine Addiction
Keywords
Methamphetamine, Drug Abuse, Drug Treatment, Addiction, Meth, Treatment for Methamphetamine Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dextroamphetamine
Arm Type
Active Comparator
Arm Description
Active drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of drug
Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine
Intervention Description
1 week placebo and 8 weeks 60mg d-AMP QD.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
9 weeks of placebo 60mg capsules QD.
Primary Outcome Measure Information:
Title
Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)
Time Frame
Twice per week for 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-50 yrs. old
Exclusion Criteria:
pregnant or lactating females
Contact site for additional information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gantt Galloway, PharmD
Organizational Affiliation
Addiction Pharmacology Research Laboratory
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
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