A Phase 3 interventional study of Ethanol and Saline in Alcohol Use Disorder, sponsored by Ohio State University. Suspended at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Ohio State University · Phase 3, Interventional, and Basic science
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.
Rates of heavy drinking and Alcohol Use Disorder (AUD) are increasing in women at an alarming pace. Such drastic increases in drinking will have a significant negative impact on women's health. Unfortunately, until recently heavy drinking has been considered a male-oriented problem, and consequently research on alcohol-related harms in women has been minimal. One specific aspect of women's health that may be negatively affected by alcohol is sleep. Numerous studies in men show that although alcohol has an initial sedative effect, it leads to frequent awakenings and impaired rapid eye movement sleep in the second half of the night.
Preliminary evidence suggests that women experience similar impairment, and that they may be even more sensitive to alcohol-disrupted sleep than men. Further, in the general population, women are at greater risk for insomnia and sleep disturbances than men, in part because women's sleep is sensitive to fluctuations in ovarian hormones. Hormonal influences on sleep are especially pronounced in older women of late reproductive age. However, the influence of sex and sex hormones on alcohol-disrupted sleep across the reproductive lifespan in women is unknown.
Here, investigators will determine the influence of sex, menstrual cycle phase, and sex hormones on alcohol-disrupted sleep in adults across the reproductive age range for women. Healthy women and men (age 21-45) will complete two pairs of experimental sessions in which they receive a dose of alcohol (target breath alcohol content [BrAC] = 100mg%, intravenous) or placebo (saline) one hour prior to eight hours of polysomnographically-monitored sleep in the lab. 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. Participants will also complete two 5-day at-home monitoring periods of naturalistic sleep and alcohol consumption patterns during the mid-follicular and late luteal phases. Sleep and alcohol use will be assessed with actigraphy, daily sleep and wake diaries, and alcohol wrist sensors.
Investigators hypothesize that women will show greater disruption of sleep following alcohol than men and that alcohol-disrupted sleep, measured in lab with polysomnography and at-home with actigraphy, 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.
This study will provide essential information regarding alcohol effects on sleep across the reproductive age span in women, and critically, how these effects are moderated by sex, menstrual cycle, and fluctuations in sex hormones. Findings will directly inform future interventions aimed at reducing alcohol consumption and the negative impacts of alcohol on sleep in women. Given the wide-ranging impact of sleep on other areas of function, including cognition, stress, and well-being, such interventions will have a substantial positive impact on women's health.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 130 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
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Exclusion Criteria:
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
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
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
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
Sterile, 95% ethanol will be administered through IV infusion
Saline is administered as the placebo
Slow Wave Sleep Minutes
Number of minutes participants spend in slow wave sleep during the night
Time frame: 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
Time frame: Night 2 (placebo, late luteal phase; 8 hours)
Slow Wave Sleep Minutes
Number of minutes participants spend in slow wave sleep during the night
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Night 4 (placebo, mid-follicular phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed \*100
Time frame: Night 1 (alcohol administration, late luteal phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed \*100
Time frame: Night 2 (placebo, late luteal phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed \*100
Time frame: Night 3 (alcohol administration, mid-follicular phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed \*100
Time frame: Night 4 (placebo, mid-follicular phase; 8 hours)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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