- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00305292
Modafinil-Alcohol Interactions in Healthy Volunteers
March 23, 2011 updated by: University of California, San Francisco
"Modafinil-Alcohol Interactions Assessed Using Tests of Thermal Stimulation, Cognition, Mood, and Motor Function in Healthy Volunteers"
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.
Study Overview
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.
Study Type
Interventional
Enrollment
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94115
- UCSF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, non-smoking adults who are 21 - 50 years of age.
- 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.
- Must have a Body Mass Index (BMI)>18 and <30.
- 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]).
- Able and willing to provide written informed consent.
- Able to understand and follow the instructions of the investigator, including all rating scales.
- Develops temporary secondary hyperalgesia from the brief thermal sensitization stimulation procedure performed at the screening visit (Session 1).
- Have a breath alcohol concentration (BAC) of 0.00 and a negative urine drug screen at all visits.
Exclusion Criteria:
- 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.
- Binge drinking more than once a week (>5 standard drinks in one session is a binge).
- Currently trying to quit alcohol and/or "recreational" drug use.
- 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.
- Positive for lifetime abnormal opioid use or prescription drug abuse.
- 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.
- 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.
- Current tobacco users.
- Use of any prescription medication (including topical), except birth control pills.
- 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.
- Bilirubin or creatinine is more than 2 times the upper limit of normal range.
- AST (SGOT), ALT (SGPT) or alkaline phosphatase is more than 2 ½ times the upper limit of normal range.
- Positive urine drug screen or pregnancy test
- Women of child bearing potential not currently using adequate means of contraception.
- 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.
- 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.
- Chronic pain condition requiring regular physician visits and treatment under a physician's supervision.
- Neurological dysfunction or psychiatric disorder severe enough to interfere with assessment of pain and sensory systems
- Subjects receiving treatment with topical steroids (prescription or OTC) in areas to be stimulated.
- Dermatopathology, skin hypersensitivity, or skin lesions in the area of measurements on the thigh and forearm.
- Heat pain detection thresholds above 47°C/116.6°F on the arm.
- Allergy to modafinil
- Has received an investigational drug within 30 days prior to Study Visit 2.
- Subjects who are unable to read or speak English.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion
August 1, 2006
Study Registration Dates
First Submitted
March 17, 2006
First Submitted That Met QC Criteria
March 17, 2006
First Posted (Estimate)
March 21, 2006
Study Record Updates
Last Update Posted (Estimate)
March 25, 2011
Last Update Submitted That Met QC Criteria
March 23, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H5612-27941-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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