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

Sponsor
University of Oregon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05684094
Collaborator
University of Pittsburgh (Other), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
90
2
48.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sleep extension and advance
  • Behavioral: Regular sleep duration and timing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep Duration and Timing to Reward- and Stress-Related Brain Function
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Feb 28, 2027
Anticipated Study Completion Date :
Feb 28, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Behavioral: 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.

Active Comparator: Regular sleep duration and timing "Owl Routine"

Participants go to bed at their typical average bedtime

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.

Outcome Measures

Primary Outcome Measures

  1. Alcohol use frequency [2 months]

    Alcohol use frequency assessed with the Alcohol Timeline Follow-Back

  2. Alcohol use quantity [2 months]

    Alcohol use quantity assessed with the Alcohol Timeline Follow-Back

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ≤ 6 h & midpoint ≥ 4 am; n=60) or long and early sleep (weekday sleep duration ≥ 8h & midpoint ≤2:30 am; n=30), which will be determined with the Munich Chronotype Questionnaire;

  4. at least moderate lifetime exposure to stressors (>6 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 and delayed sleep phase disorder;

  4. lifetime diagnosis of bipolar or schizophrenia spectrum disorder;

  5. moderate to high suicide risk;

  6. certain medical conditions (e.g., neurological disorder, heart failure or trouble, high blood pressure, 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. travel across two or more time zones within the month prior to the overnight study visits.

  10. begin/end a prescribed medication within 2 months of the observational study;

  11. 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;

  12. participant-anticipated changes in prescribed medications or medication dosing during the observational or experimental studies;

  13. self-reported use of opioids, benzodiazepines, hallucinogens, or stimulants (other than caffeine and nicotine) within 24 hours of study visits;

  14. self-reported symptoms of withdrawal from depressants or stimulants on days of study visits; and

  15. use of melatonin if participant is not willing to discontinue use for the duration of the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Melynda D Casement, PhD, University of Oregon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oregon
ClinicalTrials.gov Identifier:
NCT05684094
Other Study ID Numbers:
  • 217901
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023