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Alcohol and Sex Hormones' Effects on Sleep

Phase 3

Recruiting

Research Sponsored by Lauren Whitehurst

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

21-45 years old

Report drinking at least twice per week and at least weekly binge episodes (4/5+ drinks for women/men in a 2-hour period)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up night 4 (placebo, mid-follicular phase; 8 hours)

Awards & highlights

Pivotal Trial

Summary

This trial will investigate how alcohol affects sleep in women & men and how this is affected by sex hormones.

Who is the study for?

This trial is for adults aged 21-45 who drink alcohol at least twice a week, including weekly binge episodes. Women must have regular menstrual cycles. Participants need to be fluent in English and have at least a high school education.

What is being tested?

The study examines how sex hormones and the menstrual cycle phase affect sleep disruption by alcohol in men and women. It involves two lab sessions with either an alcohol dose or placebo, followed by sleep monitoring, plus at-home sleep tracking.

What are the potential side effects?

While not explicitly stated, potential side effects may include typical reactions to alcohol such as headache, nausea, dehydration, disrupted sleep patterns, dizziness, and hangover symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 45 years old.

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I drink alcohol at least twice a week and have weekly binge episodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ night 4 (placebo, mid-follicular phase; 8 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~night 4 (placebo, mid-follicular phase; 8 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and night 4 (placebo, mid-follicular phase; 8 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rapid Eye Movement Sleep Minutes

Sleep Efficiency

Slow Wave Sleep Minutes

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Alcohol Administration - Mid-Follicular PhaseExperimental Treatment1 Intervention

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.

Group II: Alcohol Administration - Late Luteal PhaseExperimental Treatment1 Intervention

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.

Group III: Placebo - Late Luteal PhasePlacebo Group1 Intervention

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.

Group IV: Placebo - Mid-Follicular PhasePlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ethanol

2005

Completed Phase 4

~3000

0 / 2Eligibility criteria met