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Sponsors and Collaborators: |
University of Arkansas NIDA Baylor Medications Development Center |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00569374 |
This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.
Condition | Intervention | Phase |
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Methamphetamine Dependence |
Drug: Modafinil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Tolerability of Modafinil for Methamphetamine Dependence |
Estimated Enrollment: | 8 |
Study Start Date: | September 2007 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Dr. Janette McGaugh, MD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Carole Hamon ) |
Study ID Numbers: | Protocol / IRB # 79045 |
Study First Received: | December 5, 2007 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00569374 |
Health Authority: | United States: Food and Drug Administration |
Methamphetamine Amphetamine Modafinil |
Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions |