A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Methamphetamine Addiction Clinical Trial

— 1D  

Official title:

A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630682
• Other study ID #: 25.139
• Secondary ID: P50DA018179
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2008
• Last updated: May 30, 2013
• Start date: September 2006
• Est. completion date: August 2011

Study information

• Verified date: May 2013
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18-50 yrs. old

Exclusion Criteria:

• pregnant or lactating females

• Contact site for additional information

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine Addiction

Intervention

Drug:
• Dextroamphetamine
1 week placebo and 8 weeks 60mg d-AMP QD.
• Placebo
9 weeks of placebo 60mg capsules QD.

Locations

Country	Name	City	State
United States	CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No