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NCT00469508 · ClinicalTrials.gov registry record · Phase 2
Modafinil vs Placebo for the Treatment of Methamphetamine Dependence
A Phase 2 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT00469508 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 71 participants.
The verdict
NCT00469508, a Phase 2 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise mechanism of action in promoting wakefulness remains unclear. This trial is a placebo-controlled double-blind trial of modafinil, on a platform of contingency management (CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of methamphetamine dependence. Participants in this study will complete a 2-week baseline screening period during which they will provide urine samples and complete physical and psychological assessments to establish their eligibility for the study. In addition, participants will be asked to provide a blood or saliva specimen for genetic testing in order to identify genetic variations that influence response to methamphetamine and to treatment with modafinil. Upon successful completion of screening, participants will be randomly assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study. Neither the participants nor study staff will know who is receiving active medication or placebo. Regardless of medication condition, all participants will receive CM and weekly individual CBT counseling sessions to help them stop using methamphetamine and prevent relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or the Rancho Cucamonga site) three times per week, providing urine samples at each visit, completing data measures, and receiving individual CBT counseling on one visit each week. At the end of the 12-week study, the medication or placebo will be discontinued. Participants will return to the research site approximately 30 days following medication discontinuation for a brief health check to assess any possible lingering side effects and complete brief data measures.
Interventions
- DRUG Placebo
- DRUG Modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00469508
The ClinicalTrials.gov registry entry for NCT00469508 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00469508 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00469508 about?
NCT00469508 is a clinical study titled "Modafinil vs Placebo for the Treatment of Methamphetamine Dependence". Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise mechanism of action in promoting wakefulness remains unclear. This trial is a placebo-controlled double-blind trial of ...
What is the current status of trial NCT00469508?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2007-04. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00469508?
The interventions under investigation include: Placebo (DRUG), Modafinil (DRUG).
Who is sponsoring clinical trial NCT00469508?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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