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
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, P50 DA018179
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:
Methamphetamine
Drug Abuse
Drug Treatment
Addiction
Meth
Treatment for Methamphetamine Dependence

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

ClinicalTrials.gov processed this record on July 24, 2014