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

This study has been completed.
Information provided by (Responsible Party):
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute Identifier:
First received: February 28, 2008
Last updated: May 30, 2013
Last verified: May 2013
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 Intervention Phase
Methamphetamine Addiction
Drug: Dextroamphetamine
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by California Pacific Medical Center Research Institute:

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) [ Time Frame: Twice per week for 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2006
Study Completion Date: August 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-50 yrs. old

Exclusion Criteria:

  • pregnant or lactating females

    • Contact site for additional information
  Contacts and Locations
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Please refer to this study by its identifier: NCT00630682

United States, California
CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory
San Francisco, California, United States, 94110
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Principal Investigator: Gantt Galloway, PharmD Addiction Pharmacology Research Laboratory
  More Information

Responsible Party: Gantt Galloway, PharmD, Scientist, California Pacific Medical Center Research Institute Identifier: NCT00630682     History of Changes
Other Study ID Numbers: 25.139  P50DA018179 
Study First Received: February 28, 2008
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by California Pacific Medical Center Research Institute:
Drug Abuse
Drug Treatment
Treatment for Methamphetamine Dependence

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors processed this record on October 25, 2016