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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Regular sleep duration and timing, Regular sleep schedule, Healthy sleep habits, Adequate sleep duration, Sleep extension and advance, Sleep extension therapy, Gradual sleep extension, Sleep advancement therapy for alcohol use?

Research shows that improving sleep regularity and timing can enhance sleep quality in individuals with alcohol dependence. A study found that participants with alcohol dependence who improved their sleep regularity experienced better sleep quality and reduced mental and physical exhaustion. ^{1 2 3 4 5}

Is maintaining a regular sleep schedule safe for humans?

Research on sleep interventions, such as maintaining a regular sleep schedule, generally suggests they are safe for humans. Studies have shown that improving sleep regularity can enhance sleep quality and reduce sleepiness without significant adverse effects. ^{1 2 4 6 7}

How does this sleep intervention treatment differ from other treatments for alcohol use?

This treatment is unique because it focuses on improving sleep quality through education and behavioral changes, such as stopping alcohol intake at bedtime, rather than using medication. It highlights the connection between sleep and alcohol use, offering a non-drug approach to potentially enhance sleep and reduce alcohol consumption. ^{1 2 4 8 9}

Research Team

Melynda D Casement, PhD

Principal Investigator

University of Oregon

Eligibility Criteria

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

Have at least moderate lifetime exposure to stressors

Meet NIAAA criteria for past-month high-risk drinking

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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 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]

References

1. Japan 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. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep Regularity Index in Patients with Alcohol Dependence: Daytime Napping and Mood Disorders as Correlates of Interest. [2020]

3. United States 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. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep and circadian risk factors for alcohol problems: a brief overview and proposed mechanisms. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Sleep abnormalities during abstinence in alcohol-dependent patients. Aetiology and management. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Dose-response effects of ethanol on the sleep of young women. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Alcohol and sleep I: effects on normal sleep. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Using Web-Based Social Media to Recruit Heavy-Drinking Young Adults for Sleep Intervention: Prospective Observational Study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Sleep quality during alcohol withdrawal with bright light therapy. [2019]