Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function

NCT ID: NCT05684094

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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High-risk drinking (consuming ≥ 4 drinks/day or ≥ 8/week for women, ≥ 5 drinks/day or ≥ 15/week for men) is reported by one in four young adults within the past month and predicts the development and progression of alcohol use disorder (AUD). High-risk drinking can also have terrible costs beyond developing AUD, including death and disability from unintended injuries and suicide attempts, physical and sexual assault, and a wide range of acute and chronic health problems. The high degree of morbidity and mortality associated with high- risk drinking in young adulthood makes this a key developmental period for AUD research and intervention.

High-risk drinking in young adults is related to high exposure to stressors, insufficient sleep duration, and late sleep timing. Alarmingly, almost half of young adults report at least moderate exposure to stressors, only 30% regularly obtain the recommended hours of sleep, and sleep timing is at its latest around age 20. Stressors and short/late sleep may also cause disruptions in reward- and stress-related brain function (e.g., medial prefrontal cortex response to monetary reward, autonomic and neuroendocrine function during stressors), which are key biobehavioral mechanisms of AUD. Short and late sleep habits are a prime target for AUD prevention in young adults; however, there is insufficient causal evidence that improving sleep opportunity and/or timing will alter the biobehavioral mechanisms of AUD or decrease high-risk drinking, particularly in at-risk young adults.

The overall objective of this R01 is to evaluate a biobehavioral model whereby sufficient sleep duration and/or early sleep timing can reduce high-risk drinking by promoting reward- and stress-related brain function in young adults with high lifetime stress load. The long-term goal of this research is to leverage sleep and circadian function to promote mental health. A series of studies by the PI and Co-I Hasler demonstrate that stressful life events, short sleep, and late sleep independently predict future reward- and stress-related brain function and alcohol use and dependence symptoms in adolescents and young adults. However, these studies do not evaluate the additive and interactive effects of stressful life events and sleep/circadian function and do not include experimental designs. More recent research by the PI and Co-I Hasler uses sleep and circadian manipulation to target reward- and stress-related brain function and improve mental health in adolescents and young adults. Building from this research, this R01 will test the central hypothesis that extending and advancing sleep will alter reward- and stress-related brain function in young adults with a history of high-risk drinking and elevated lifetime exposure to stressors. This proposal is consistent with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Strategic Objective to identify mechanisms underlying AUD and comorbid disorders.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Sleep extension and advance "Lark Routine"

Participants go to bed 90 minutes earlier than their typical average bedtime to extend sleep duration and advance sleep timing

Group Type EXPERIMENTAL

Sleep extension and advance

Intervention Type BEHAVIORAL

Participants in the sleep extension and advance condition will maintain a stable sleep schedule that extends sleep duration and advances bedtime by 90 min relative to weekday bedtime. This chronotherapeutic manipulation will include blocking phase-delaying light in the evening using goggles with orange lenses ("blue blockers") beginning 2 h prior to bedtime, and 30 min of 506 lux blue-green light exposure in the morning beginning at rise time using bright light goggles (ReTimer Pty Ltd., Australia). Schedule and chronotherapy adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.

Regular sleep duration and timing "Owl Routine"

Participants go to bed at their typical average bedtime

Group Type ACTIVE_COMPARATOR

Regular sleep duration and timing

Intervention Type BEHAVIORAL

Participants in the regular sleep duration and timing condition will keep a stable sleep schedule that matches their typical weekday sleep opportunity and timing. Schedule adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.

Interventions

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Sleep extension and advance

Participants in the sleep extension and advance condition will maintain a stable sleep schedule that extends sleep duration and advances bedtime by 90 min relative to weekday bedtime. This chronotherapeutic manipulation will include blocking phase-delaying light in the evening using goggles with orange lenses ("blue blockers") beginning 2 h prior to bedtime, and 30 min of 506 lux blue-green light exposure in the morning beginning at rise time using bright light goggles (ReTimer Pty Ltd., Australia). Schedule and chronotherapy adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.

Intervention Type BEHAVIORAL

Regular sleep duration and timing

Participants in the regular sleep duration and timing condition will keep a stable sleep schedule that matches their typical weekday sleep opportunity and timing. Schedule adherence will be reinforced using motivational techniques (e.g., securing motivation, preplanning, problem-solving), requiring participants to text the study coordinator and complete morning assessments at rise time, and monetary incentives.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 ≤ 7.5 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);
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 clinician-provided diagnosis of narcolepsy or idiopathic hypersomnia;
4. lifetime diagnosis of bipolar or schizophrenia spectrum disorder;
5. certain medical conditions (e.g., serious neurological disorder, heart failure or serious trouble, history of head injury with unconsciousness \> 5 minutes);
6. conditions that are contraindicated for MRI (e.g., ferrous metal in the body);
7. 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);
8. 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. urgent suicide risk, defined by moderate/severe risk per CSSR and clinician determination that current risk requires immediate action;
2. travel across two or more time zones within the month prior to the overnight study visits.
3. begin/end a prescribed medication within 2 months of the observational study;
4. 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;
5. participant-anticipated changes in prescribed medications or medication dosing during the observational or experimental studies.;
6. 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 visit date.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Oregon

OTHER

Sponsor Role lead

Responsible Party

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Melynda Casement

Associate Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melynda D Casement, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

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Oregon Sleep Lab

Eugene, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda Johnson

Role: CONTACT

541-346-4107

Facility Contacts

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Research Associate

Role: primary

541-346-0392

Other Identifiers

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R01AA029125

Identifier Type: NIH

Identifier Source: secondary_id

View Link

217901

Identifier Type: -

Identifier Source: org_study_id

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