A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Public ClinicalTrials.gov record NCT00538655. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00538655
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2007
- Primary completion
- Dec 31, 2008
- Completion
- May 31, 2011
- Last update posted
- Jun 2, 2013
2008 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab | San Francisco | California | 94110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00538655, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2013 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00538655 live on ClinicalTrials.gov.