Sleep Interventions for Alcohol Use

(MoRA Trial)

Overseen By Amanda Johnson

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Must not be taking: Neuroleptics, Psoralen, Antiarrhythmics, Antimalarials

Disqualifiers: Severe AUD/SUD, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep patterns affect alcohol use in young adults, aiming to develop better prevention methods for alcohol use disorders. Participants will try different sleep routines: one group will maintain their usual sleep schedule ("Regular sleep duration and timing"), while another will go to bed 90 minutes earlier ("Sleep extension and advance"). It targets young adults who drink regularly, sleep less than 7 hours on weekdays, and often go to bed late. As an unphased trial, this study allows participants to contribute to innovative research that could lead to improved prevention strategies for alcohol use disorders.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that you should not begin or change prescribed medications close to the study period. If you use melatonin, you will need to stop for the duration of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that getting more sleep and going to bed earlier are generally safe and well-tolerated. One study found that people who tried to sleep more did not experience any serious side effects. They slept longer and reported feeling healthier overall.

Additionally, better sleep has been linked to less risky drinking in people who drink heavily. This suggests that focusing on sleep might not only be safe but also helpful for those with potential alcohol problems.

Overall, no major unwanted effects have been reported with these sleep changes. Going to bed earlier and sleeping longer appears to be a safe way to improve sleep and possibly reduce alcohol use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these sleep interventions for alcohol use because they offer a new, non-pharmaceutical approach to tackling alcohol-related issues. Unlike standard treatments that often rely on medications or therapy to manage alcohol use disorders, these interventions focus on improving sleep patterns, which can have a profound impact on overall health and behavior. The "Owl Routine" maintains regular sleep habits, while the "Lark Routine" involves going to bed earlier to extend and advance sleep timing. By targeting sleep, these methods aim to reduce alcohol consumption and improve recovery, offering a potentially safer and more holistic option compared to traditional treatments.

What evidence suggests that this trial's sleep interventions could be effective for alcohol use?

This trial will compare two sleep interventions for alcohol use. Participants in one arm will follow the "Owl Routine," maintaining their regular sleep duration and timing. Research has shown that going to bed earlier and sleeping longer, as in the "Lark Routine" arm where participants go to bed 90 minutes earlier, can improve sleep quality. One study found that people who went to bed earlier slept about 12 minutes more on weekdays, benefiting overall health. Other research indicates that better sleep can help people drink less alcohol over time. Specifically, those who improved their sleep habits achieved better results than those who only received advice. These findings suggest that better sleep can help reduce risky alcohol use. ^{1 2 6 7 8}

Who Is on the Research Team?

Melynda D Casement, PhD

Principal Investigator

University of Oregon

Are You a Good Fit for This Trial?

This trial is for English-speaking young adults aged 18-24 who engage in high-risk drinking as defined by NIAAA and have specific sleep patterns. They must have experienced moderate stress in their lifetime but can't participate if they've recently traveled across time zones, changed medications, or are at risk of suicide.

Inclusion Criteria

Have short and late sleep or long and early sleep as determined by the Munich Chronotype Questionnaire

Meet NIAAA criteria for past-month high-risk drinking

Have at least moderate lifetime exposure to stressors

Exclusion Criteria

Acute alcohol intoxication on the days of the laboratory post-intensive visits

Lifetime diagnosis of bipolar or schizophrenia spectrum disorder

I do not have serious heart issues, neurological disorders, or a history of significant head injuries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants follow either the 'Owl Routine' or 'Lark Routine' to assess the impact of sleep duration and timing on alcohol use and brain function

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in alcohol use and brain function after the treatment phase

2 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Regular sleep duration and timing
• Sleep extension and advance

Trial Overview The study investigates how life stress and sleep habits (both duration and timing) relate to alcohol use in young adults. It aims to understand these connections better to eventually help prevent alcohol use disorders.

How Is the Trial Designed?

Group I: Sleep extension and advance "Lark Routine" Experimental Treatment 1 Intervention

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

Group II: Regular sleep duration and timing "Owl Routine" Active Control 1 Intervention

Participants go to bed at their typical average bedtime

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Social media advertising targeting sleep concerns effectively reached young adults who drink heavily, with 13,638 clicks and 27 enrolled volunteers over 3 months, indicating a promising recruitment strategy for alcohol prevention programs.

Advertisements focused on sleep had a significantly higher response rate (0.91%) compared to those targeting alcohol use (0.56%), suggesting that addressing sleep issues may be a more appealing approach for engaging this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Web-Based Social Media to Recruit Heavy-Drinking Young Adults for Sleep Intervention: Prospective Observational Study. Ash, GI., Robledo, DS., Ishii, M., et al.[2021]

In a study of 124 participants with alcohol use disorder undergoing inpatient treatment, the Sleep Regularity Index (SRI) showed a significant increase from week 1 to week 3, indicating improved sleep quality and regularity during treatment.

Higher SRI scores were linked to reduced nap duration and lower levels of mental and physical exhaustion, suggesting that enhancing sleep regularity could be beneficial for individuals with alcohol dependence, especially those without mood disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Regularity Index in Patients with Alcohol Dependence: Daytime Napping and Mood Disorders as Correlates of Interest. Brooks, AT., Raju, S., Barb, JJ., et al.[2020]

In a pilot study involving 10 alcohol-dependent patients, bright light therapy (3000 Lux) was administered during alcohol withdrawal, leading to significant improvements in sleep onset latency and subjective sleep quality after treatment.

The results suggest that bright light therapy may help stabilize sleep patterns and improve sleep architecture during acute alcohol withdrawal, although further controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep quality during alcohol withdrawal with bright light therapy. Schmitz, M., Frey, R., Pichler, P., et al.[2019]

Alcohol ingestion reduces the time it takes to fall asleep and increases the amount of slow wave sleep (SWS) in the first half of the night, but it also leads to more sleep disruptions in the second half.

High doses of alcohol significantly decrease the percentage of rapid eye movement (REM) sleep throughout the night and delay the onset of the first REM sleep period, indicating a clear negative impact on REM sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol and sleep I: effects on normal sleep. Ebrahim, IO., Shapiro, CM., Williams, AJ., et al.[2022]

Sleep and circadian rhythm disturbances are significant but often overlooked factors that can lead to the initiation and worsening of alcohol use among adolescents and young adults.

The review proposes a conceptual model highlighting two pathways—positive and negative reinforcement—showing how sleep and circadian factors are linked to alcohol use, suggesting that understanding these connections could inform future research and interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and circadian risk factors for alcohol problems: a brief overview and proposed mechanisms. Hasler, BP., Pedersen, SL.[2021]

Alcohol-dependent patients experience a wide range of sleep problems, including longer time to fall asleep, decreased sleep efficiency, and disrupted sleep architecture, which can persist even after months or years of abstinence.

Current treatments like benzodiazepines and SSRIs are not recommended for improving sleep in these patients; instead, nonpharmacological strategies such as sleep hygiene, bright light therapy, and relaxation techniques are suggested, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep abnormalities during abstinence in alcohol-dependent patients. Aetiology and management. Landolt, HP., Gillin, JC.[2018]

In a study of healthy young women, increasing doses of alcohol led to a decrease in rapid eye movement (REM) sleep, which is important for cognitive functions and emotional regulation.

The study also found that higher alcohol consumption increased slow-wave sleep (which is restorative), decreased the time it took to fall asleep, but resulted in more disturbances during late-night sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response effects of ethanol on the sleep of young women. Williams, DL., MacLean, AW., Cairns, J.[2019]

A 4.5-hour sleep education program for 40 high school employees led to a significant decrease in sleepiness, as indicated by a 1.2-point reduction in the Epworth Sleepiness Scale score (P = 0.04).

Participants who reduced their alcohol intake at bedtime experienced the most improvement in sleep conditions, suggesting that the combination of education and lifestyle changes can enhance sleep quality, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on the effects of a 1-day sleep education program: influence on sleep of stopping alcohol intake at bedtime. Morita, E., Miyazaki, S., Okawa, M.[2021]

In a study of 24 recently alcohol-abstinent chronic alcoholics, significant sleep deterioration and a high prevalence of sleep apnea episodes were observed, highlighting potential sleep quality issues in this population.

The findings suggest that both men and women experienced sleep apnea at similar rates, which is a new observation, indicating the need for systematic screening for sleep apnea in alcoholics seeking treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in detoxified alcoholics: impairment of most standard sleep parameters and increased risk for sleep apnea, but not for myoclonias--a controlled study. Le Bon, O., Verbanck, P., Hoffmann, G., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10476177/

Behavioral interventions to extend sleep duration The goal of this study was to examine the effects of behavioral sleep extension interventions on sleep duration outcomes in children and adults ≥ age 12.

2. withpower.com withpower.com/trial/sleep-interventions-for-alcohol-use-059ad

Sleep Interventions for Alcohol Use (MoRA Trial) This treatment is unique because it focuses on improving sleep quality through education and behavioral changes, such as stopping alcohol intake at bedtime, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834652

Wearable Intervention for Alcohol Use Risk and Sleep in ... All conditions had clinically meaningful drinking reductions over time, but the intervention showed a benefit over advice alone for other sleep ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899925/

Efficacy of sleep extension therapy using a remote support ... The results of the questionnaire-based survey revealed that the intervention group increased their weekday sleep duration by about 12 min. The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1087079224001345

The effect of alcohol on subsequent sleep in healthy adults For every additional hour that alcohol was consumed prior to bedtime, REM sleep duration in the alcohol condition was increased by 0.06 min (95%CI = −0.1 to 0 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38099849/

Effects of a digital cognitive behavioral therapy for ... Improving sleep may be an effective treatment intervention for reducing hazardous drinking in at-risk individuals.

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07658-6

a randomized controlled study of a behavioral sleep extension ... The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12125640/

Wearable Intervention for Alcohol Use Risk and Sleep in ... Is a wearable feedback and coaching intervention efficacious for improving at-risk drinking and sleep health in young adults?