RECRUITING

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

Conditions

Alcohol Use Disorder sleep circadian adolescence substance use stress reward

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-07

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05684094

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 24 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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. 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.

Inclusion Criteria

Exclusion 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.

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.
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.

Contacts and Locations

Study Contact

Amanda Johnson

CONTACT

541-346-4107

anj@uoregon.edu

Principal Investigator

Melynda D Casement, PhD

PRINCIPAL_INVESTIGATOR

University of Oregon

Study Locations (Sites)

Oregon Sleep Lab

Eugene, Oregon, 97403

United States

Collaborators and Investigators

Sponsor: University of Oregon

Melynda D Casement, PhD, PRINCIPAL_INVESTIGATOR, University of Oregon

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-07

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2023-09-07

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

sleep
circadian
adolescence
substance use
stress
reward

Additional Relevant MeSH Terms

Alcohol Use Disorder