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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630682
First Posted: March 7, 2008
Last Update Posted: June 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Gantt Galloway, PharmD, 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 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-50 yrs. old

Exclusion Criteria:

  • pregnant or lactating females

    • Contact site for additional information
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630682


Locations
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
Investigators
Principal Investigator: Gantt Galloway, PharmD Addiction Pharmacology Research Laboratory
  More Information

Responsible Party: Gantt Galloway, PharmD, Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00630682     History of Changes
Other Study ID Numbers: 25.139
P50DA018179 ( U.S. NIH Grant/Contract )
First Submitted: February 28, 2008
First Posted: March 7, 2008
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Gantt Galloway, PharmD, California Pacific Medical Center Research Institute:
Methamphetamine
Drug Abuse
Drug Treatment
Addiction
Meth
Treatment for Methamphetamine Dependence

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Methamphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors