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

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sleep extension and advance

Regular sleep duration and timing

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring sleep, circadian, adolescence, substance use, stress, reward

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion 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 ≤ 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; at least moderate lifetime exposure to stressors (>6 events on the 20-item Adult Stress and Adversity Inventory-Screener); not currently in high school; and English language fluency. Exclusion Criteria: 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 sleep disorders other than insomnia and delayed sleep phase disorder; lifetime diagnosis of bipolar or schizophrenia spectrum disorder; moderate to high suicide risk; certain medical conditions (e.g., neurological disorder, heart failure or trouble, high blood pressure, 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); 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; self-reported use of opioids, benzodiazepines, hallucinogens, or stimulants (other than caffeine and nicotine) within 24 hours of study visits; self-reported symptoms of withdrawal from depressants or stimulants on days of study visits; and use of melatonin if participant is not willing to discontinue use for the duration of the study. If possible, participants who are excluded for positive breathalyzer screen, self-reported substance use within 24 hours of study visits, or symptoms of withdrawal during study visits will be rescheduled for an alternative overnight visit within 2-3 days. Participants who are excluded for moderate to high suicide risk, recent or anticipated changes in medications, or travel across time-zones will become eligible for the study when they no longer meet these exclusion criteria.

Sites / Locations

Oregon Sleep LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep extension and advance "Lark Routine"

Regular sleep duration and timing "Owl Routine"

Arm Description

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

Participants go to bed at their typical average bedtime

Outcomes

Primary Outcome Measures

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.

Reward-related brain function

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

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. The TSST is a lab-based social-evaluative threat task that reliably elicits subjective stress and increases in the stress-hormone cortisol.

Secondary Outcome Measures

Full Information

NCT ID

NCT05684094

First Posted

January 4, 2023

Last Updated

April 28, 2023

Sponsor

University of Oregon

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05684094

Brief Title

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

Acronym

MoRA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 19, 2023 (Actual)

Primary Completion Date

February 28, 2027 (Anticipated)

Study Completion Date

February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oregon

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

Detailed Description

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 NIAAA Strategic Objective to identify mechanisms underlying AUD and comorbid disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

sleep, circadian, adolescence, substance use, stress, reward

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sleep extension and advance "Lark Routine"

Arm Type

Experimental

Arm Description

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

Arm Title

Regular sleep duration and timing "Owl Routine"

Arm Type

Active Comparator

Arm Description

Participants go to bed at their typical average bedtime

Intervention Type

Behavioral

Intervention Name(s)

Sleep extension and advance

Intervention Description

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

Intervention Name(s)

Regular sleep duration and timing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Alcohol use

Description

Time Frame

2 months

Title

Reward-related brain function

Description

Time Frame

2 weeks

Title

Stress-related brain function

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Konyn, PhD

Phone

541-346-0392

akonyn@uoregon.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melynda D Casement, PhD

Organizational Affiliation

University of Oregon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Sleep Lab

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97403

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Research Associate

Phone

541-346-0392

akonyn@uoregon.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Raw data and data from descriptive/raw measures, as described in the data sharing agreement, will be submitted on a semi-annual basis by July 15 and January 15 or the next business day, beginning on January 15, 2023.

IPD Sharing 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.

IPD Sharing 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 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 CV, 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 University of Oregon 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.

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

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