Alcohol Use DisorderPhase 3NCT06143059
The Effects of Sex Hormones and Alcohol on Sleep
A Phase 3 study testing Ethanol and Saline in people with Alcohol Use Disorder, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Ethanol and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 1 Nov 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sex and Sex Hormone Factors Influencing Acute Alcohol Effects on Sleep Physiology
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.
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Ethanol, Saline
- Keywords
- Sex hormones, Sleep disruption
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
Sterile, 95% ethanol will be administered through IV infusion
SalineDrug
Saline is administered as the placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow Wave Sleep Minutes
Number of minutes participants spend in slow wave sleep during the night
Measured: 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
Measured: Night 2 (placebo, late luteal phase; 8 hours)
Slow Wave Sleep Minutes
Number of minutes participants spend in slow wave sleep during the night
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Night 4 (placebo, mid-follicular phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed *100
Measured: Night 1 (alcohol administration, late luteal phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed *100
Measured: Night 2 (placebo, late luteal phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed *100
Measured: Night 3 (alcohol administration, mid-follicular phase; 8 hours)
Sleep Efficiency
Amount of time spent asleep / amount of time in bed *100
Measured: Night 4 (placebo, mid-follicular phase; 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start8 Jan 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Why it stopped: PI transferring work elsewhere
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jessica Weafer, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143059
- Sponsor's protocol ID
- STUDY20250392
- Other IDs
- R01AA030308
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex and Sex Hormone Factors Influencing Acute Alcohol Effects on Sleep Physiology
- ClinicalTrials.gov ID
- NCT06143059
- Acronym / sponsor ID
- STUDY20250392
- Conditions
- Alcohol Use Disorder
- Keywords
- Sex hormones, Sleep disruption
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI transferring work elsewhere
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alcohol Administration - Late Luteal Phase | Experimental | Drug: EthanolDuring 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. |
| Placebo - Late Luteal Phase | Placebo comparator | Drug: SalineDuring 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. |
| Alcohol Administration - Mid-Follicular Phase | Experimental | Drug: EthanolDuring 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. |
| Placebo - Mid-Follicular Phase | Placebo comparator | Drug: SalineDuring 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 may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EthanolSterile, 95% ethanol will be administered through IV infusion | Drug | Alcohol Administration - Late Luteal Phase, Alcohol Administration - Mid-Follicular Phase |
| SalineSaline is administered as the placebo | Drug | Placebo - Late Luteal Phase, Placebo - Mid-Follicular Phase |
Primary outcome
Slow Wave Sleep Minutes
Time frame: Night 1 (alcohol administration, late luteal phase; 8 hours)
Number of minutes participants spend in slow wave sleep during the night
Slow Wave Sleep Minutes
Time frame: Night 2 (placebo, late luteal phase; 8 hours)
Number of minutes participants spend in slow wave sleep during the night
Slow Wave Sleep Minutes
Time frame: Night 3 (alcohol administration, mid-follicular phase; 8 hours)
Number of minutes participants spend in slow wave sleep during the night
Slow Wave Sleep Minutes
Time frame: Night 4 (placebo, mid-follicular phase; 8 hours)
Number of minutes participants spend in slow wave sleep during the night
Rapid Eye Movement Sleep Minutes
Time frame: Night 1 (alcohol administration, late luteal phase; 8 hours)
Number of minutes participants spend in rapid eye movement (REM) sleep during the night
Rapid Eye Movement Sleep Minutes
Time frame: Night 2 (placebo, late luteal phase; 8 hours)
Number of minutes participants spend in rapid eye movement (REM) sleep during the night
Rapid Eye Movement Sleep Minutes
Time frame: Night 3 (alcohol administration, mid-follicular phase; 8 hours)
Number of minutes participants spend in rapid eye movement (REM) sleep during the night
Rapid Eye Movement Sleep Minutes
Time frame: Night 4 (placebo, mid-follicular phase; 8 hours)
Number of minutes participants spend in rapid eye movement (REM) sleep during the night
Wake After Sleep Onset
Time frame: Night 1 (alcohol administration, late luteal phase; 8 hours)
Number of one minute arousal epochs after sleep was initiated during the night
Wake After Sleep Onset
Time frame: Night 2 (placebo, late luteal phase; 8 hours)
Number of one minute arousal epochs after sleep was initiated during the night
Wake After Sleep Onset
Time frame: Night 3 (alcohol administration, mid-follicular phase; 8 hours)
Number of one minute arousal epochs after sleep was initiated during the night
Wake After Sleep Onset
Time frame: Night 4 (placebo, mid-follicular phase; 8 hours)
Number of one minute arousal epochs after sleep was initiated during the night
Sleep Efficiency
Time frame: Night 1 (alcohol administration, late luteal phase; 8 hours)
Amount of time spent asleep / amount of time in bed *100
Sleep Efficiency
Time frame: Night 2 (placebo, late luteal phase; 8 hours)
Amount of time spent asleep / amount of time in bed *100
Sleep Efficiency
Time frame: Night 3 (alcohol administration, mid-follicular phase; 8 hours)
Amount of time spent asleep / amount of time in bed *100
Sleep Efficiency
Time frame: Night 4 (placebo, mid-follicular phase; 8 hours)
Amount of time spent asleep / amount of time in bed *100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethanol and Saline in people with Alcohol Use Disorder, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow Wave Sleep Minutes (time frame: Night 1 (alcohol administration, late luteal phase; 8 hours)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.