The Effects of Sex Hormones and Alcohol on Sleep

• Status: Recruiting
• Trial end date: 2028-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lauren Whitehurst
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Ohio State University
• Treatments: Ethanol

Criteria

Inclusion Criteria:

• 21-45 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

Exclusion Criteria:

• 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