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New treatment option for Alcohol Use Disorder
Official title Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function
ClinicalTrials.gov ID: NCT05684094
What this study is testing
- What it's testing
- This research will use biobehavioral approaches to generate understanding about the linkages between stressful life events, sleep duration and timing, and alcohol use in young adults, with a long-term aim of developing effective preventative interventions for alcohol use disorders.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 24
You may be able to join if
- 18-24 years of age;
- 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);
- short and late sleep (weekday sleep duration ≤ 7.5 hours and bedtime ≥ 24:00 (midnight); n=60) or long and early sleep (weekday sleep duration \> 7.5...
- at least moderate lifetime exposure to stressors (≥ 2 events on the 20-item Adult Stress and Adversity Inventory-Screener);
- not currently in high school; and
You likely can't join if
- Severe alcohol use disorder (AUD) and/or substance use disorder (SUD), defined as ≥6 AUD/SUD criteria in the Diagnostic and Statistical Manual-5;
- acute alcohol intoxication on the days of the laboratory post-intensive visits, operationalized as a blood alcohol concentration of .02 or higher...
- current clinician-provided diagnosis of narcolepsy or idiopathic hypersomnia;
- lifetime diagnosis of bipolar or schizophrenia spectrum disorder;
- certain medical conditions (e.g., serious neurological disorder, heart failure or serious trouble, history of head injury with unconsciousness \> 5...
- conditions that are contraindicated for MRI (e.g., ferrous metal in the body);
See the full eligibility criteria
- 18-24 years of age;
- 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);
- short and late sleep (weekday sleep duration ≤ 7.5 hours and bedtime ≥ 24:00 (midnight); n=60) or long and early sleep (weekday sleep duration \> 7.5 hours and bedtime ≤ 24:00 (midnight); n=30);
- at least moderate lifetime exposure to stressors (≥ 2 events on the 20-item Adult Stress and Adversity Inventory-Screener);
- not currently in high school; and
- English language fluency.
- Severe alcohol use disorder (AUD) and/or substance use disorder (SUD), defined as ≥6 AUD/SUD criteria in the Diagnostic and Statistical Manual-5;
- 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;
- current clinician-provided diagnosis of narcolepsy or idiopathic hypersomnia;
- lifetime diagnosis of bipolar or schizophrenia spectrum disorder;
- certain medical conditions (e.g., serious neurological disorder, heart failure or serious trouble, history of head injury with unconsciousness \> 5 minutes);
- conditions that are contraindicated for MRI (e.g., ferrous metal in the body);
- 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...
- 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:
- urgent suicide risk, defined by moderate/severe risk per CSSR and clinician determination that current risk requires immediate action;
- travel across two or more time zones within the month prior to the overnight study visits.
- begin/end a prescribed medication within 2 months of the observational study;
- 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;
- participant-anticipated changes in prescribed medications or medication dosing during the observational or experimental studies.;
- current symptoms of an airborne infectious illness (e.g., COVID) prior to laboratory visits. Participants with positive breathalyzer screen (blood alcohol level \> .02) will be rescheduled for an alternative overnight...
The study team makes the final eligibility decision.
Where it's taking place
- Eugene, Oregon, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Eugene, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.