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| Sponsor: | California Pacific Medical Center Research Institute |
|---|---|
| Information provided by: | California Pacific Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT00630097 |
Purpose
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. 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 coadministered with intravenous methamphetamine. We will conduct a placebo-controlled, randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance Dependence Amphetamine Dependence |
Drug: modafinil |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Dose Ranging Study of Modafinil for Methamphetamine Dependence |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Kathleen Garrison | 415-641-3370 | garrisk@cpmcri.org |
| United States, California | |
| CPMC | |
| San Francisco, California, United States, 94110 | |
| Principal Investigator: | Gantt Galloway, PharmD | California Pacific Medical Center |
More Information
| Responsible Party: | California Pacific Medical Center Research Institute ( Gantt Galloway ) |
| Study ID Numbers: | 27.140 |
| Study First Received: | February 27, 2008 |
| Last Updated: | February 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00630097 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
methamphetamine addiction, meth dependence |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Stimulants Protective Agents Neuroprotective Agents |
Modafinil Pharmacologic Actions Methamphetamine Amphetamine-Related Disorders Mental Disorders Autonomic Agents Therapeutic Uses Substance-Related Disorders Amphetamine Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
