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Modafinil-Alcohol Interactions in Healthy Volunteers

This study has been terminated.
(This study should be terminated as the study closed prior to 2007 and the investigator has since retired. No records are available.)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305292
First received: March 17, 2006
Last updated: March 23, 2011
Last verified: March 2011
  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"

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 32
Study Start Date: March 2006
Estimated Study Completion Date: August 2006
Detailed Description:

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
Criteria

Inclusion Criteria:

  1. Healthy, non-smoking adults who are 21 - 50 years of age.
  2. Social or moderate drinkers who drink up to 14 drinks per week and are capable of drinking 3 drinks in a 90 minute time period.
  3. Must have a Body Mass Index (BMI)>18 and <30.
  4. If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or double barrier method [male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream]).
  5. Able and willing to provide written informed consent.
  6. Able to understand and follow the instructions of the investigator, including all rating scales.
  7. Develops temporary secondary hyperalgesia from the brief thermal sensitization stimulation procedure performed at the screening visit (Session 1).
  8. Have a breath alcohol concentration (BAC) of 0.00 and a negative urine drug screen at all visits.

Exclusion Criteria:

  1. Current or prior enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer.
  2. Binge drinking more than once a week (>5 standard drinks in one session is a binge).
  3. Currently trying to quit alcohol and/or "recreational" drug use.
  4. Use of cocaine, amphetamines or other stimulants, hallucinogens, "ecstasy", or other psychoactive drugs, greater than 10 times in the last 24 months or at anytime in the past 60 days.
  5. Positive for lifetime abnormal opioid use or prescription drug abuse.
  6. Abusing inhalants (such as glue, toluene or other volatile substances), PCP, or ketamine greater than 10 times in the last 24 months, or at anytime in the past 60 days.
  7. 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.
  8. Current tobacco users.
  9. Use of any prescription medication (including topical), except birth control pills.
  10. 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.
  11. Bilirubin or creatinine is more than 2 times the upper limit of normal range.
  12. AST (SGOT), ALT (SGPT) or alkaline phosphatase is more than 2 ½ times the upper limit of normal range.
  13. Positive urine drug screen or pregnancy test
  14. Women of child bearing potential not currently using adequate means of contraception.
  15. Coronary artery disease, uncontrolled hypertension, cardiac conduction abnormalities or significant arrhythmias, orthostatic mean blood pressure drop > than 25 mmHg, severe chronic obstructive pulmonary disease, or frequent headaches.
  16. Any other clinically significant medical or psychiatric illness as determined by medical history, physical exam or screening blood tests, as judged by the study physician.
  17. Chronic pain condition requiring regular physician visits and treatment under a physician's supervision.
  18. Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of pain and sensory systems
  19. Subjects receiving treatment with topical steroids (prescription or OTC) in areas to be stimulated.
  20. Dermatopathology, skin hypersensitivity, or skin lesions in the area of measurements on the thigh and forearm.
  21. Heat pain detection thresholds above 47°C/116.6°F on the arm.
  22. Allergy to modafinil
  23. Has received an investigational drug within 30 days prior to Study Visit 2.
  24. Subjects who are unable to read or speak English.
  25. Those, in the opinion of the investigator, who are considered unable to adhere to scheduled appointments, unlikely to comply with the study protocol, or who are unsuitable for any other reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305292

Locations
United States, California
UCSF
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Michael C Rowbotham, MD University of California, San Francisco
  More Information

No publications provided

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

Additional relevant MeSH terms:
Armodafinil
Ethanol
Modafinil
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents

ClinicalTrials.gov processed this record on November 25, 2014