A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence (1D)

May 30, 2013 updated by: Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-50 yrs. old

Exclusion Criteria:

  • pregnant or lactating females

    • Contact site for additional information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Twice per week for 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Investigators

  • Principal Investigator: Gantt Galloway, PharmD, Addiction Pharmacology Research Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2013

Last Update Submitted That Met QC Criteria

May 30, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25.139
  • P50DA018179 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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