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NCT06143059
The Effects of Sex Hormones and Alcohol on Sleep
Phase 3 trial testing Ethanol in Alcohol Use Disorder in 130 participants. Suspended.
1 August 2028
Quick facts
| Lead sponsor | Lauren Whitehurst |
|---|---|
| Phase | Phase 3 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 130 |
| Start date | 8 January 2024 |
| Primary completion | 1 August 2028 |
| Estimated completion | 1 November 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ethanol (Ethanol) — full drug profile →
- Saline
Conditions studied
- Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
Sponsor
Lauren Whitehurst
Who can join
Adults 21 to 45, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06143059
- Europe PMC full search
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- medRxiv preprints
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Other recruiting trials for Alcohol Use Disorder
Currently open trials in the same condition.
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- NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06143059 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lauren Whitehurst
- Last refreshed: 20 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06143059.
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