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AlcoholNCT00305292

Modafinil-Alcohol Interactions in Healthy Volunteers

A study testing Modafinil-Alcohol Interactions in people with Alcohol, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol
What is being tested?
Modafinil-Alcohol Interactions
How many people
32 participants
Where
1 siteUnited States
Study dates
Mar 2006to Aug 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: "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.

Read the 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.

Conditions
Alcohol
Being tested
Modafinil-Alcohol Interactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modafinil-Alcohol InteractionsDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2006 (estimated)
  2. Study startMar 2006
  3. Study completionAug 2006

Why it stopped: This study should be terminated as the study closed prior to 2007 and the investigator has since retired. No records are available.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
32 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00305292
Sponsor's protocol ID
H5612-27941-01
Status last verified
Mar 2011
First submitted
17 Mar 2006
Last updated
25 Mar 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Modafinil-Alcohol Interactions in people with Alcohol, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: This study should be terminated as the study closed prior to 2007 and the investigator has since retired. No records are available.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00305292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2011.

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