A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Phase 2

Completed

• Conditions: Methamphetamine Addiction
• Interventions: Drug: Placebo; Drug: Dextroamphetamine

• Registration Number: NCT00630682
• Lead Sponsor: California Pacific Medical Center Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Primary Completion: 2009-03
• Study Completion: 2011-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-50 yrs. old

Exclusion Criteria

• pregnant or lactating females

  • Contact site for additional information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo of drug
Dextroamphetamine	Dextroamphetamine	Active drug

Primary Outcome Measures

Name	Time	Method
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)	Twice per week for 8 weeks

Trial Locations

Locations (1)

CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory; 🇺🇸 San Francisco, California, United States