Phase
Condition
Sleep Disorders
Insomnia
Treatment
Placebo Gum
Caffeine Gum
Clinical Study ID
Ages 18-39 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-39 years of age
Must demonstrate adequate comprehension of the protocol by achieving a score of atleast 80% correct on a short multiple-choice quiz
Exclusion
Exclusion Criteria:
Self-reported habitual nightly sleep amounts outside the target range ofapproximately 6-9 hours (i.e., less than 6 hours per night or more than 9 hours pernight, on average)
Self-reported nighttime bedtimes earlier than approximately 2100 hours on averageduring weeknights (Sunday through Thursday)
Self-reported morning wake-up times later than approximately 0900 on average duringweekdays (Monday through Friday)
Self-reported habitual napping (> 3 times per week)
Self-reported symptoms suggestive of a sleep disorder (to include but not limited tosleep disordered breathing/sleep apnea, narcolepsy, idiopathic hypersomnia, restlessleg syndrome, parasomnias, rapid eye movement (REM) behavior disorder, etc.)
History of a sleep disorder (to include all of the above)
Any use of prescription or over-the-counter sleep aids during the 6-month periodprior to screening indicative of a potential sleep disorder as determined by theexamining study physician
History of neurologic disorder (e.g., seizure disorder, amnesia for any reason,hydrocephalus, multiple sclerosis)
Self-reported caffeine use > 400 mg per day on average
Score of 14 or above on the Beck Depression Inventory (BDI)
Score of 41 or above on the Spielberger Trait Anxiety Inventory (STAI-T)
Score below 31 or above 69 on the Morningness-Eveningness Questionnaire
Self-reported regular nicotine use (> 1 cigarette or equivalent per week) within thelast 1 year) or positive nicotine/cotinine result during screening visit
Self-reported heavy alcohol use (≥14 drinks per week or as determined by theexamining study physician) or positive saliva alcohol result during screening visit
History of cardiovascular disease (to include but not limited to arrhythmias,valvular heart disease, congestive heart failure, history of sudden cardiac death ormyocardial infarction)
Underlying acute or chronic pulmonary disease requiring daily inhaler use
Kidney disease or kidney abnormalities
Liver disease or liver abnormalities
Self-reported history of psychiatric disorder requiring hospitalization or use ofpsychiatric medication for any length of time
Self-reported use of products or drugs that cannot be safely discontinued duringin-laboratory phases (determined on a case-by-case basis by the examining studyphysician)
Self-reported current use of other illicit drugs (to include but not limited tobenzodiazepines, amphetamines, cocaine, marijuana) or positive urine drug screen
(Females only) positive urine pregnancy result
(Females only) self-reported or suspected current breast-feeding or collectingbreast milk
Resting blood pressure above 140/90 or resting pulse > 110 beats per minute (if aphysician performs a repeat measurement, ~20 minutes after original measure, and itis within range, volunteer will not be excluded)
BMI ≥ 30 (Obese Class I or greater)
Clinically significant values (as determined by the reviewing study physician) forany hematology or chemistry parameter
Inability to read and sign consent
(Military only) failure to obtain required approved official leave to participate
Failure to cooperate with requirements of the study, e.g. failure to complete 80% ofSmart-Psychomotor Vigilance Tests (PVTs) during Phase 1 (Days 2-13)
Study Design
Study Description
Connect with a study center
University of Arizona
Tucson, Arizona 85719
United StatesSite Not Available
University of Arizona Psychiatry Department
Tucson, Arizona 85724
United StatesActive - Recruiting
University of Arizona
Tucson 5318313, Arizona 5551752 85719
United StatesActive - Recruiting
University of Arizona Psychiatry Department
Tucson 5318313, Arizona 5551752 85724
United StatesActive - Recruiting

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