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| Sponsored by: |
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: | Health Services Research, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: |
|
| 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:
Use of caffeine or alcohol within 24 hours prior to the drug treatment sessions, or during study week except the alcohol supplied in the study.
Heavy caffeine users who cannot tolerate stopping caffeine without symptoms are excluded.
Use of any OTC medications during or 24 hours prior to study, including NSAIDS and “herbal” preparations (unless cleared by study physician).
Exception is acetaminophen, which can be taken during the study period, but not within 12 hours prior or during the drug and alcohol study sessions 2-3.
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
| Study ID Numbers: | H5612-27941-01 |
| Study First Received: | March 17, 2006 |
| Last Updated: | January 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00305292 History of Changes |
| Health Authority: | United States: Federal Government |
|
Central Nervous System Stimulants Healthy Neuroprotective Agents Modafinil Ethanol |
|
Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Modafinil |