Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05684094
Eligibility Criteria:
Inclusion Criteria:
1. 18-24 years of age;
2. NIAAA criteria for past-month high-risk drinking (i.e., ≥ 4 drinks/day or ≥ 8/week for women, ≥ 5 drinks/day or ≥ 15/week for men);
3. short and late sleep (weekday sleep duration ≤ 7 hours and bedtime ≥ 24:00 (midnight); n=60) or long and early sleep (weekday sleep duration ≥ 7 hours and bedtime ≤ 24:00 (midnight); n=30), which will be determined with the Munich Chronotype Questionnaire;
4. at least moderate lifetime exposure to stressors (≥ 2 events on the 20-item Adult Stress and Adversity Inventory-Screener);
5. not currently in high school; and
6. English language fluency.
Exclusion Criteria:
1. Severe alcohol use disorder (AUD) and/or substance use disorder (SUD), defined as ≥6 AUD/SUD criteria in the Diagnostic and Statistical Manual-5;
2. acute alcohol intoxication on the days of the laboratory post-intensive visits, operationalized as a blood alcohol concentration of .02 or higher during Breathalyzer saliva screen;
3. current sleep disorders other than insomnia, delayed sleep phase disorder, or hypersomnia;
4. lifetime diagnosis of bipolar or schizophrenia spectrum disorder;
5. urgent suicide risk, defined by moderate/severe risk as per Columbia Suicide Severity Rating (CSSR) Community Card, and clinician determination that current risk requires immediate action, precluding engagement in study;
6. certain medical conditions (e.g., serious neurological disorder, heart failure or serious trouble, history of head injury with unconsciousness \> 5 minutes);
7. conditions that are contraindicated for MRI (e.g., ferrous metal in the body);
8. positive screen for participant-reported eye disease, epilepsy, or photosensitizing medications that are contraindicated during the manipulation condition when bright light is administered (e.g., psychiatric neuroleptic drugs \[e.g., phenothiazine\], psoralen drugs, antiarrhythmic drugs \[e.g., amiodarone\], antimalarial and antirheumatic drugs, porphyrin drugs used in photodynamic treatment of skin diseases);
9. use of melatonin if participant is not willing to discontinue use for the duration of the study.
We will schedule around (i.e., delay appointments as needed) to avoid the timeframe of the following events:
1. travel across two or more time zones within the month prior to the overnight study visits.
2. begin/end a prescribed medication within 2 months of the observational study;
3. medication dose changes within the timeframe calculated as 5x the drug's half-life \[the time to reach pharmacokinetic steady-state\] before the initiation of the observational or experimental studies;
4. participant-anticipated changes in prescribed medications or medication dosing during the observational or experimental studies.
Participants with positive breathalyzer screen (blood alcohol level \> .02) will be rescheduled for an alternative overnight visit date. Participants excluded for suicide risk may become eligible for the study when the risk has dissipated. We will reschedule participants who have current symptoms of an airborne infectious illness (e.g., COVID).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
24 Years
Study:
NCT05684094
Study Brief:
Protocol Section:
NCT05684094