Alcohol Use DisorderMoRANCT05684094
Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function
A study testing Sleep extension and advance and Regular sleep duration and timing in people with Alcohol Use Disorder, run by University of Oregon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Sleep extension and advance and Regular sleep duration and timing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 ≤ 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.
Who cannot join
- 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);
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- 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.
- Participants with positive breathalyzer screen (blood alcohol level > .02) will be rescheduled for an alternative overnight visit date.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Sleep Lab
Eugene, Oregon, 97403
Research Associate, 541-346-0392, akonyn@uoregon.edu
About this study
Official title: Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep Duration and Timing to Reward- and Stress-Related Brain Function
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.
Read the 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 National Institute on Alcohol Abuse and Alcoholism (NIAAA) Strategic Objective to identify mechanisms underlying AUD and comorbid disorders.
- Conditions
- Alcohol Use Disorder
- Being tested
- Sleep extension and advance, Regular sleep duration and timing
- Keywords
- sleep, circadian, adolescence, substance use, stress, reward
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep extension and advanceBehavioural
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 timingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Sleep extension and advance |
| Regular sleep duration and timing "Owl Routine" | Active comparator | Participants go to bed at their typical average bedtime Receives: Behavioral: Regular sleep duration and timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start7 Sep 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Melynda Casement, University of Oregon
- Investigators
- Melynda D Casement, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684094
- Sponsor's protocol ID
- 217901
- Other IDs
- R01AA029125
- Acronym
- MoRA
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep Duration and Timing to Reward- and Stress-Related Brain Function
- ClinicalTrials.gov ID
- NCT05684094
- Acronym / sponsor ID
- MoRA / 217901
- Conditions
- Alcohol Use Disorder
- Keywords
- sleep, circadian, adolescence, substance use, stress, reward
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- University of Pittsburgh, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 National Institute on Alcohol Abuse and Alcoholism (NIAAA) Strategic Objective to identify mechanisms underlying AUD and comorbid disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep extension and advance "Lark Routine" | Experimental | Behavioral: Sleep extension and advanceParticipants go to bed 90 minutes earlier than their typical average bedtime to extend sleep duration and advance sleep timing |
| Regular sleep duration and timing "Owl Routine" | Active comparator | Behavioral: Regular sleep duration and timingParticipants go to bed at their typical average bedtime |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 ≤ 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
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep extension and advanceParticipants 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. | Behavioural | Sleep extension and advance "Lark Routine" |
| Regular sleep duration and timingParticipants 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. | Behavioural | Regular sleep duration and timing "Owl Routine" |
Primary outcome
Alcohol use
Time frame: 2 months
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
Time frame: 2 weeks
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
Stress-related brain function
Time frame: 2 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melynda D Casement, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep extension and advance and Regular sleep duration and timing in people with Alcohol Use Disorder, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Johnson (541-346-4107, anj@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol use (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.