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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00305292 |
Purpose
The UCSF Pain Clinical Research Center (PCRC) is conducting a study of the effects of modafinil (Provigil®; Vigiver, Alertec), alcohol and the combination on alertness, mood, visual motor and cognitive performance, and pain sensation. Modafinil is a stimulant drug marketed as a wakefulness and alertness promoting medication.
| Condition | Intervention |
|---|---|
|
Alcohol |
Drug: Modafinil-Alcohol Interactions |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Health Services Research |
| Official Title: | "Modafinil-Alcohol Interactions Assessed Using Tests of Thermal Stimulation, Cognition, Mood, and Motor Function in Healthy Volunteers" |
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | August 2006 |
The exact mechanism of action is unclear, and evidence has been gathered supporting a variety of different mechanisms including activity in a part of the brain that regulates wakefulness and alertness. The interaction between modafinil and alcohol has not been studied. The purpose of this study is to expand knowledge of the mood, memory, decision making, and pain relieving effects of each drug and how modafinil alters the effects of alcohol.
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF | |
| San Francisco, California, United States, 94115 | |
| Principal Investigator: | Michael C Rowbotham, MD | University of California, San Francisco |
More Information
| ClinicalTrials.gov Identifier: | NCT00305292 History of Changes |
| Other Study ID Numbers: | H5612-27941-01 |
| Study First Received: | March 17, 2006 |
| Last Updated: | March 23, 2011 |
| Health Authority: | United States: Federal Government |
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Ethanol Modafinil Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Central Nervous System Stimulants Neuroprotective Agents Protective Agents |