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NCT00538655 · ClinicalTrials.gov registry record · Phase 2
A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
A Phase 2 study, sponsored by California Pacific Medical Center Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00538655 is a Phase 2 study that has completed, run by California Pacific Medical Center Research Institute. The registered enrollment target is 20 participants.
The verdict
NCT00538655, a Phase 2 study, has completed, sponsored by California Pacific Medical Center Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-\[(diphenylmethyl) sulfinyl\] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence. Specific Aims: 1. Determine the safety of modafinil in the treatment of methamphetamine dependence. 2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence. 3. Assess the effect of modafinil on cognitive function in methamphetamine users. 4. Assess the effect of modafinil on methamphetamine withdrawal symptoms. 5. Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring. Hypotheses: 1. Modafinil will be as safe and well tolerated as placebo in a comparison group from another study. 2. Subjects given modafinil will use less methamphetamine than subjects given placebo. 3. Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo. 4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo. 5. Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.
Interventions
- DRUG modafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00538655
The ClinicalTrials.gov registry entry for NCT00538655 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is California Pacific Medical Center Research Institute, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which modafinil is the first listed.
NCT00538655 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00538655 about?
NCT00538655 is a clinical study titled "A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence". Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-\[(diphenylmethyl) sulfinyl\] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimil...
What is the current status of trial NCT00538655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2008-01. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00538655?
The interventions under investigation include: modafinil (DRUG).
Who is sponsoring clinical trial NCT00538655?
This trial is sponsored by California Pacific Medical Center Research Institute, which has 29 total clinical trials registered on ClinicalTrials.gov.
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