A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence (1D)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||August 2011|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Dextroamphetamine
1 week placebo and 8 weeks 60mg d-AMP QD.
Placebo Comparator: Placebo
Placebo of drug
9 weeks of placebo 60mg capsules QD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630682
|United States, California|
|CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Gantt Galloway, PharmD||Addiction Pharmacology Research Laboratory|