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| Sponsored by: |
California Pacific Medical Center Research Institute |
|---|---|
| Information provided by: | California Pacific Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT00630682 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Dextroamphetamine: Active Comparator
Active drug
|
Drug: Dextroamphetamine
1 week placebo and 8 weeks 60mg d-AMP QD.
|
|
Placebo: Placebo Comparator
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 |
Inclusion Criteria:
Exclusion Criteria:
pregnant or lactating females
Contacts and Locations| Contact: Jennifer D Siegrist | 415-641-2107 | siegrij@cpmcri.org |
| United States, California | |
| CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Jennifer D Siegrist 415-641-3370 siegrij@cpmcri.org | |
| Principal Investigator: Gantt Galloway, PharmD | |
| Principal Investigator: John Mendelson, MD | |
| Principal Investigator: | Gantt Galloway, PharmD | Addiction Pharmacology Research Laboratory |
More Information
| Responsible Party: | Addiction Pharmacology Research Laboratory ( Gantt Galloway ) |
| Study ID Numbers: | 25.139, P50 DA018179 |
| Study First Received: | February 28, 2008 |
| Last Updated: | January 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00630682 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
Methamphetamine Drug Abuse Drug Treatment |
Addiction Meth Treatment for Methamphetamine Dependence |
|
Methamphetamine Behavior, Addictive Dopamine Dextroamphetamine Amphetamine |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
