A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence (1D)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by California Pacific Medical Center Research Institute.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
California Pacific Medical Center Research Institute
Information provided by:
California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00630682
First received: February 28, 2008
Last updated: February 5, 2009
Last verified: January 2009
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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:
MedlinePlus related topics:
Methamphetamine
Drug Information available for:
Methamphetamine hydrochloride
Dextroamphetamine sulfate
Dextroamphetamine
Amphetamine
Methamphetamine
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | March 2009 |
| Estimated 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
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, Addiction Pharmacology Research Laboratory |
| ClinicalTrials.gov Identifier: | NCT00630682 History of Changes |
| Other Study ID Numbers: | 25.139, P50 DA018179 |
| Study First Received: | February 28, 2008 |
| Last Updated: | February 5, 2009 |
| 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 Amphetamine 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 May 16, 2013