Alcohol and Sex Hormones' Effects on Sleep

Overseen By Lauren Whitehurst, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Lauren Whitehurst

Must not be taking: Antidepressants, Anxiolytics, Beta-blockers, others

Disqualifiers: Liver disease, Diabetes, Insomnia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how alcohol affects sleep differently in men and women, with a particular focus on women's menstrual cycles and sex hormones. Researchers aim to determine if women experience more sleep disruption from alcohol than men and whether these effects vary at different points in their menstrual cycle. Participants will receive either alcohol or a placebo (a harmless substitute) and have their sleep monitored in a controlled lab setting. Individuals with a regular drinking pattern, such as weekly binge episodes, may be well-suited for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to important research on alcohol's impact on sleep.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that affect sleep or heart function, such as antidepressants or beta-blockers, and any medications that should not be mixed with alcohol.

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

Research shows that alcohol can affect sleep patterns. Studies have found that while alcohol might help individuals fall asleep faster, it often disrupts sleep later in the night. Specifically, alcohol can interfere with REM sleep, the stage when dreaming occurs. It can also cause more frequent awakenings and reduce overall sleep quality.

Previous studies suggest that alcohol might increase heart rate during sleep, though the effects the next morning are usually mild. Although alcohol is commonly consumed and generally safe in moderate amounts, its impact on sleep can vary among individuals. In this trial, researchers are closely monitoring the safety of alcohol. Participants will receive alcohol in a controlled setting with medical supervision to minimize risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the unique interplay between alcohol, sex hormones, and sleep. Unlike current treatments that might separately address sleep disorders, hormonal imbalances, or alcohol use, this study investigates how these elements interact within the body, providing a holistic view. By examining the effects of alcohol administered at specific menstrual phases and comparing them with a placebo, the trial aims to uncover new insights into how hormonal cycles affect sleep patterns. This could lead to more personalized strategies for managing sleep disorders linked to hormonal changes.

What evidence suggests that this trial's treatments could be effective for alcohol-disrupted sleep?

Research has shown that alcohol can make it harder to stay asleep and can lower sleep quality. In both men and women, alcohol helps with falling asleep faster but causes more frequent awakenings during the night. These effects can be stronger in women due to hormonal changes. This trial will examine alcohol's impact on sleep during different phases of the menstrual cycle. Participants will receive alcohol during either the mid-follicular or late luteal phases. Studies suggest that alcohol might disrupt sleep more during the late luteal phase, when progesterone levels are higher. Overall, alcohol interferes with achieving restful and restorative sleep. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-45 who drink alcohol at least twice a week, including weekly binge episodes. Women must have regular menstrual cycles. Participants need to be fluent in English and have at least a high school education.

Inclusion Criteria

You have completed high school.

Women have regular periods every 21 to 35 days.

I am between 21 and 45 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Mid-Follicular Phase

Participants receive alcohol or placebo intravenously during the mid-follicular phase and are monitored with polysomnography during sleep

1-2 days

2 lab sessions (in-person)

Treatment - Late Luteal Phase

Participants receive alcohol or placebo intravenously during the late luteal phase and are monitored with polysomnography during sleep

1-2 days

2 lab sessions (in-person)

At-home Monitoring

Participants complete at-home monitoring of naturalistic sleep and alcohol consumption patterns using actigraphy, sleep diaries, and alcohol wrist sensors

5 days per phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol
• Sex Hormones

Trial Overview

The study examines how sex hormones and the menstrual cycle phase affect sleep disruption by alcohol in men and women. It involves two lab sessions with either an alcohol dose or placebo, followed by sleep monitoring, plus at-home sleep tracking.

How Is the Trial Designed?

Group I: Alcohol Administration - Mid-Follicular Phase Experimental Treatment 1 Intervention

During the mid-follicular phase of a female participant's menstrual cycle, participants will complete a lab session where alcohol is administered intravenously. The infusion will include a 30-minute linear ascension from 0mg% breath alcohol content (BrAC) to 100mg%, followed by a 60-minute 'clamping' of BrAC at 100mg%. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the placebo session at intervals that are matched to the female subjects. The placebo and alcohol sessions during mid-follicular luteal phase will take place 1-2 days apart, and their order will be randomized.

Group II: Alcohol Administration - Late Luteal Phase Experimental Treatment 1 Intervention

During the late luteal phase of a female participant's menstrual cycle, participants will complete a lab session where alcohol is administered intravenously. The infusion will include a 30-minute linear ascension from 0mg% breath alcohol content (BrAC) to 100mg%, followed by a 60-minute 'clamping' of BrAC at 100mg%. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the placebo session at intervals that are matched to the female subjects. The placebo and alcohol sessions during late luteal phase will take place 1-2 days apart, and their order will be randomized.

Group III: Placebo - Late Luteal Phase Placebo Group 1 Intervention

During the late luteal phase of a female participant's menstrual cycle, participants will complete a lab session where saline is administered intravenously, as placebo, for 90 minutes. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the experimental session at intervals that are matched to the female subjects. The placebo and alcohol sessions during late luteal phase will take place 1-2 days apart, and their order will be randomized.

Group IV: Placebo - Mid-Follicular Phase Placebo Group 1 Intervention

During the mid-follicular phase of a female participant's menstrual cycle, participants will complete a lab session where saline is administered intravenously, as placebo, for 90 minutes. Subjects will then be monitored while they sleep, using polysomnography. Male subjects will complete this and the experimental session at intervals that are matched to the female subjects. The placebo and alcohol sessions during mid-follicular phase will take place 1-2 days apart, and their order will be randomized.

Who Is Running the Clinical Trial?

Lauren Whitehurst

Lead Sponsor

Trials

1

Recruited

130+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Moderate to high doses of alcohol can suppress testosterone levels in men, although some studies show conflicting results; alcohol may inhibit testosterone production directly in the testes.

In women, alcohol does not decrease estradiol or affect LH levels during the late follicular phase, and it can actually increase levels of estradiol, progesterone, and testosterone during the midluteal phase, suggesting different hormonal responses to alcohol between genders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of ethanol on sex hormones in non-alcoholic men and women. Ellingboe, J.[2013]

Testosterone levels in men are closely linked to sleep, with levels rising during sleep and peaking during REM sleep, indicating that good sleep is important for maintaining healthy testosterone levels.

Sleep disturbances, such as reduced sleep efficiency and increased sleep apnea, are associated with lower testosterone levels, suggesting that sleep quality may play a crucial role in regulating male sexual health and endocrine function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of testosterone on sleep and sleep-disordered breathing in men: its bidirectional interaction with erectile function. Andersen, ML., Tufik, S.[2013]

In a study involving castrated male rats, exogenous estradiol (E) was found to increase wakefulness during the active phase and enhance recovery of REM sleep after sleep deprivation, suggesting a potential role in sleep modulation.

Compared to control groups, rats treated with estradiol showed higher cortical activation during both wakefulness and REM sleep, indicating that E may improve sleep quality in conditions of androgen deprivation, which warrants further investigation in men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estradiol treatment modulates spontaneous sleep and recovery after sleep deprivation in castrated male rats. Wibowo, E., Deurveilher, S., Wassersug, RJ., et al.[2013]

In a study of 12 male chronic alcoholics, significant hormonal changes were observed during withdrawal, including increased levels of luteinizing hormone, estradiol, and cortisol, compared to 14 healthy volunteers.

After 21 days of abstinence, estradiol and cortisol levels decreased, but luteinizing hormone levels remained elevated, suggesting that alcohol may disrupt testosterone production and lead to compensatory hormonal changes that could affect clinical symptoms in chronic alcoholics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypothalamic-pituitary-gonadal axis, prolactin, and cortisol in alcoholics during withdrawal and after three weeks of abstinence: comparison with healthy control subjects. Heinz, A., Rommelspacher, H., Gräf, KJ., et al.[2022]

In a study of 87 premenopausal women, alcohol consumption significantly increased total and free testosterone levels, particularly in women using oral contraceptives, suggesting a potential impact on hormone levels related to alcohol intake.

Alcohol also lowered androstenedione levels while increasing the testosterone to androstenedione ratio, indicating that alcohol may enhance the conversion of androstenedione to testosterone in the liver, which could have implications for conditions like hyperandrogenism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effect of alcohol on androgens in premenopausal women. Sarkola, T., Fukunaga, T., Mäkisalo, H., et al.[2019]

Sex steroids significantly influence sleep patterns and related central nervous system processes, as evidenced by both animal studies and human research, highlighting their role in sleep regulation.

The review indicates that hormonal changes, such as those occurring during menopause or throughout the menstrual cycle, can affect sleep quality and circadian rhythms in women, suggesting that sex steroids may help explain gender differences in sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex, steroids, and sleep: a review. Manber, R., Armitage, R.[2022]

In a study involving 21 premenopausal women on oral contraceptives and 10 nonusers, alcohol consumption led to an acute increase in plasma testosterone levels and a decrease in androstenedione levels, with these effects lasting throughout the alcohol elimination period.

The study suggests that alcohol affects steroid hormone levels by inhibiting their breakdown in the liver, indicating that the liver plays a significant role in the acute hormonal effects of alcohol in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the liver in the acute effect of alcohol on androgens in women. Sarkola, T., Adlercreutz, H., Heinonen, S., et al.[2022]

In a study of seven male-to-female transsexual patients undergoing cross-gender hormone therapy, estrogen treatment significantly increased the duration of stage 1 sleep, indicating a change in sleep patterns after three months of therapy.

The hormone therapy also led to a significant increase in beta activity during non-REM sleep, suggesting that while estrogen and anti-androgens have some effects on sleep EEG, the overall influence on sleep quality appears to be limited, primarily increasing shallow sleep duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the sleep electroencephalogram (EEG) during male to female transgender therapy. Künzel, HE., Murck, H., Stalla, GK., et al.[2013]

In a study of 30 male chronic alcoholics, it was found that despite normal testosterone levels upon admission, high levels of sex-hormone binding globulin (SHBG) were present, indicating potential hypoandrogenism related to alcohol use.

After a short abstinence period of about 11 days, SHBG levels significantly decreased, suggesting that SHBG could be a potential marker for alcoholism, while luteinizing hormone (LH) also decreased, indicating a possible link to hypoandrogenism in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of abstinence on sex hormone profile in alcoholic patients without liver failure. Iturriaga, H., Valladares, L., Hirsch, S., et al.[2019]

Increased estrogen levels are associated with decreased voluntary alcohol intake, while progesterone and testosterone do not show similar effects, suggesting a specific role for estrogen in alcohol consumption behavior.

High estrogen concentrations may impair the metabolism of ethanol, although the exact mechanism is still unclear, indicating a need for further research to understand how sex steroids influence alcohol pharmacokinetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sex steroids on ethanol pharmacokinetics and autonomic reactivity. Zeiner, AR., Kegg, PS.[2013]

In adult rats, a moderate dose of ethanol (1.2 g/kg) significantly increased the levels of several steroid precursors and metabolites, particularly 17-hydroxypregnenolone (by 480%) and dehydroepiandrosterone (by 430%).

Ethanol appears to inhibit the conversion of certain steroid precursors to testosterone, which may explain its role in decreasing testosterone production, while not affecting estradiol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ethanol on steroid profiles in the rat testis. Andersson, SH., Sjövall, J.[2019]

In a study of 108 women aged 20 to 50, those using progestogen-only oral contraceptives experienced the longest mean nightly sleep time (510 minutes), suggesting that certain hormonal contraceptives may positively influence sleep duration.

The study found that the route of administration of hormonal contraceptives affects sleep quality, with vaginal administration of etonorgestrel and ethinylestradiol showing the most significant improvement in subjective sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in sleep associated with different types of hormonal contraceptives. Guida, M., Rega, A., Vivone, I., et al.[2020]

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