The Effects of Sex Hormones and Alcohol on Sleep

NCT06143059 | Suspended Phase 3 FDA Drug

• 2 other identifiers: 77098R01AA030308
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Rates of heavy drinking and Alcohol Use Disorder (AUD) are increasing in women, but research on alcohol-related harms in women - including alcohol's impact on sleep - has been minimal. Numerous studies in men show that alcohol impairs sleep, and preliminary evidence suggests that women may be even more sensitive to alcohol-disrupted sleep due to their sex hormones, which fluctuate across both their menstrual cycles and their reproductive lifespans. This study will investigate the influence of sex, menstrual cycle phase, and sex hormones on alcohol-disrupted sleep in adults ages 21-45. Healthy women and men will complete two sets of placebo-controlled lab sessions, during the mid-follicular and late luteal phases of female participants' menstrual cycles. During these sessions, participants will receive a dose of alcohol or a placebo (saline) and they will then be monitored (with polysomnography) while they sleep. At-home sleep and alcohol use will also be measured through actigraphy, daily sleep and wake diaries, and alcohol wrist sensors. Investigators hypothesize that women will show greater disruption of sleep following alcohol use or administration than men, and that alcohol-disrupted sleep will be more pronounced in the late luteal phase compared to the mid-follicular phase. Investigators also expect that estradiol will be negatively associated with alcohol-disrupted sleep, whereas progesterone will be positively associated with alcohol-disrupted sleep.

Conditions

Alcohol Use Disorder

Keywords

Sex hormones; Sleep disruption

Outcome Measures

Primary Outcomes (16)

• Slow Wave Sleep Minutes

  Number of minutes participants spend in slow wave sleep during the night

  Night 1 (alcohol administration, late luteal phase; 8 hours)

• Slow Wave Sleep Minutes

  Number of minutes participants spend in slow wave sleep during the night

  Night 2 (placebo, late luteal phase; 8 hours)

• Slow Wave Sleep Minutes

  Number of minutes participants spend in slow wave sleep during the night

  Night 3 (alcohol administration, mid-follicular phase; 8 hours)

• Slow Wave Sleep Minutes

  Number of minutes participants spend in slow wave sleep during the night

  Night 4 (placebo, mid-follicular phase; 8 hours)

• Rapid Eye Movement Sleep Minutes

  Number of minutes participants spend in rapid eye movement (REM) sleep during the night

  Night 1 (alcohol administration, late luteal phase; 8 hours)

• Rapid Eye Movement Sleep Minutes

  Number of minutes participants spend in rapid eye movement (REM) sleep during the night

  Night 2 (placebo, late luteal phase; 8 hours)

• Rapid Eye Movement Sleep Minutes

  Number of minutes participants spend in rapid eye movement (REM) sleep during the night

  Night 3 (alcohol administration, mid-follicular phase; 8 hours)

• Rapid Eye Movement Sleep Minutes

  Number of minutes participants spend in rapid eye movement (REM) sleep during the night

  Night 4 (placebo, mid-follicular phase; 8 hours)

• Wake After Sleep Onset

  Number of one minute arousal epochs after sleep was initiated during the night

  Night 1 (alcohol administration, late luteal phase; 8 hours)

• Wake After Sleep Onset

  Number of one minute arousal epochs after sleep was initiated during the night

  Night 2 (placebo, late luteal phase; 8 hours)

• Wake After Sleep Onset

  Number of one minute arousal epochs after sleep was initiated during the night

  Night 3 (alcohol administration, mid-follicular phase; 8 hours)

• Wake After Sleep Onset

  Number of one minute arousal epochs after sleep was initiated during the night

  Night 4 (placebo, mid-follicular phase; 8 hours)

• Sleep Efficiency

  Amount of time spent asleep / amount of time in bed \*100

  Night 1 (alcohol administration, late luteal phase; 8 hours)

• Sleep Efficiency

  Amount of time spent asleep / amount of time in bed \*100

  Night 2 (placebo, late luteal phase; 8 hours)

• Sleep Efficiency

  Amount of time spent asleep / amount of time in bed \*100

  Night 3 (alcohol administration, mid-follicular phase; 8 hours)

• Sleep Efficiency

  Amount of time spent asleep / amount of time in bed \*100

  Night 4 (placebo, mid-follicular phase; 8 hours)

Study Arms (4)

Alcohol Administration - Late Luteal Phase

EXPERIMENTAL

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.

Drug: Ethanol

Placebo - Late Luteal Phase

PLACEBO COMPARATOR

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.

Drug: Saline

Alcohol Administration - Mid-Follicular Phase

EXPERIMENTAL

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.

Drug: Ethanol

Placebo - Mid-Follicular Phase

PLACEBO COMPARATOR

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.

Drug: Saline

Interventions

Ethanol DRUG

Sterile, 95% ethanol will be administered through IV infusion

Alcohol Administration - Late Luteal Phase; Alcohol Administration - Mid-Follicular Phase

Saline DRUG

Saline is administered as the placebo

Placebo - Late Luteal Phase; Placebo - Mid-Follicular Phase

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• At least a high school education
• Fluency in English
• Report drinking at least twice per week and at least weekly binge episodes (4/5+ drinks for women/men in a 2-hour period)
• Regular ovulatory menstrual cycles (21-35 days in length) for women

You may not qualify if:

• Any serious medical problems (e.g., liver disease, cardiac abnormality/arrhythmia, pancreatitis, diabetes, neurological problems, gastrointestinal disorders, hypertension, and congestive heart failure)
• Any clinical sleep disorder, including insomnia and obstructive sleep apnea (OSA)
• Any psychiatric condition that could affect sleep/wake cycles (including major depression, generalized anxiety disorder, bipolar disorder, and post-traumatic stress disorder)
• Any medication use that is likely to affect sleep/wake function or cardiovascular functioning (including antidepressants, anxiolytic or soporific medication, and beta-blockers)
• Taking medication for which alcohol consumption is contraindicated
• Substance use disorder other than mild or moderate alcohol use disorder
• Positive urine screen for illegal drugs other than cannabis
• Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
• Pregnancy, nursing or planning to become pregnant in the next 3 months for women
• Use of hormonal contraception or planning to begin use of hormonal contraception in the next 3 months for women
• Reports smoking \> 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)
• Has flushing response to alcohol
• Works the night shift

Sponsors & Collaborators

• Lauren Whitehurst: lead
• Ohio State University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Sodium Chloride

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lauren Whitehurst, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the nurse administering the IV alcohol or saline will know which one has been administered
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Women will complete one alcohol-placebo session pair during the mid-follicular phase of the menstrual cycle and one pair during the late luteal phase. Men will complete two session pairs at matched intervals.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 22, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)