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

NCT05684094 | Recruiting

• 2 other identifiers: 217901R01AA029125
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

sleep; circadian; adolescence; substance use; stress; reward

Outcome Measures

Primary Outcomes (3)

• Alcohol use

  The Alcohol Timeline Follow-Back (TLFB) will be administered electronically to assess the quantity (number of standard drinks) and frequency of alcohol use over the past 2 months, beginning at screening and continuing at least every 2 months through the follow-up assessment. The TLFB uses a calendar, anchor dates, and standard drink conversions to obtain retrospective estimates of alcohol use.

  2 months

• Reward-related brain function

  Functional magnetic resonance imaging (fMRI) during the Monetary Incentive Delay task (MID, 92) will be used to measure blood oxygen level dependent (BOLD) regional response and functional connectivity related to anticipation and receipt of monetary rewards. This task reliably elicits activation in neural reward circuitry

  2 weeks

• Stress-related brain function

  Stress-related brain function will be indexed using autonomic and neuroendocrine measures taken before and during the Trier Social Stress Task (TSST). The TSST is a lab-based social-evaluative threat task that reliably elicits subjective stress and increases in the stress-hormone cortisol.

  2 weeks

Study Arms (2)

Sleep extension and advance "Lark Routine"

EXPERIMENTAL

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

Behavioral: Sleep extension and advance

Regular sleep duration and timing "Owl Routine"

ACTIVE COMPARATOR

Participants go to bed at their typical average bedtime

Behavioral: Regular sleep duration and timing

Interventions

Sleep extension and advance 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.

Sleep extension and advance "Lark Routine"

Regular sleep duration and timing 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.

Regular sleep duration and timing "Owl Routine"

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify 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 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 drugs \[e.g., phenothiazine\], psoralen drugs, antiarrhythmic drugs \[e.g., amiodarone\], antimalarial and antirheumatic drugs, porphyrin drugs used in photodynamic treatment of skin diseases);
• 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.

Sponsors & Collaborators

• University of Oregon: lead
• University of Pittsburgh: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Oregon Sleep Lab

Eugene, Oregon, 97403, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Melynda D Casement, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Johnson

CONTACT

541-346-4107; anj@uoregon.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: We agree to release and share data in a timely manner, but no later than one year following completion of the funded project period or the date of publication of the main findings from our final data set.
• Access Criteria: In order to gain access to data, researchers who were not part of the original research protocol as defined by the University of Oregon Institutional Review Board (IRB) application must submit a detailed description of their project to the Investigator Committee. The proposal must include the investigator's personal identification and institutional affiliation, a current curriculum vita, qualifications, estimated duration of the proposed research, source of financial support, and a conflict of interest statement. The protocol described must include study aims, background and significance, and methods and types of analysis, and a description of the data requested and list of variables. Once approved, the investigator must complete the necessary IRB exempt research application form and document completion of a responsible conduct of research program. Data will not be provided that could identify individual research participants or that the original consent form expressly forbade.

Locations

US (1)