1D: A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Sponsor

California Pacific Medical Center Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00630682

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Addiction	Drug: Dextroamphetamine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dextroamphetamine Active drug	Drug: Dextroamphetamine 1 week placebo and 8 weeks 60mg d-AMP QD.
Placebo Comparator: Placebo Placebo of drug	Drug: Placebo 9 weeks of placebo 60mg capsules QD.

Arm

Intervention/Treatment

Active Comparator: Dextroamphetamine

Active drug

Drug: Dextroamphetamine

1 week placebo and 8 weeks 60mg d-AMP QD.

Placebo Comparator: Placebo

Placebo of drug

Drug: Placebo

9 weeks of placebo 60mg capsules QD.

Outcome Measures

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) [Twice per week for 8 weeks]