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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00630682
First received: February 28, 2008
Last updated: May 30, 2013
Last verified: May 2013

February 28, 2008
May 30, 2013
September 2006
March 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00630682 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Methamphetamine Addiction
  • Drug: Dextroamphetamine
    1 week placebo and 8 weeks 60mg d-AMP QD.
  • Drug: Placebo
    9 weeks of placebo 60mg capsules QD.
  • Active Comparator: Dextroamphetamine
    Active drug
    Intervention: Drug: Dextroamphetamine
  • Placebo Comparator: Placebo
    Placebo of drug
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
August 2011
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-50 yrs. old

Exclusion Criteria:

  • pregnant or lactating females

    • Contact site for additional information
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00630682
25.139, P50 DA018179
Yes
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
California Pacific Medical Center Research Institute
Not Provided
Principal Investigator: Gantt Galloway, PharmD Addiction Pharmacology Research Laboratory
California Pacific Medical Center Research Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP