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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rapid Eye Movement Sleep Minutes

Sleep Efficiency

Slow Wave Sleep Minutes

+1 more

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

Find a Location

Who is running the clinical trial?

Ohio State UniversityOTHER

830 Previous Clinical Trials

505,490 Total Patients Enrolled

2 Trials studying Alcoholism

224 Patients Enrolled for Alcoholism

Lauren WhitehurstLead Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,315 Total Patients Enrolled

424 Trials studying Alcoholism

985,738 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participants are most desirable for this trial's requirements?

"This medical trial is open to those aged 21-45 that have a diagnosis of alcoholism. A total of 130 participants are required for the experiment."

Answered by AI

Is the enrollment period for this trial currently open?

"Accurate. As of this time, clinicaltrials.gov states that the recruitment for participants has concluded - although it was first posted on 17th November 2023 and last updated two days ago. Nevertheless, there are still 282 other trials searching for patients currently."

Answered by AI

Is the age limit on this clinical experiment restricted to individuals over 40 years old?

"The minimum age for this trial is 21 and the maximum accepted age is 45. There are 19 trials available to people under 18, while those of 65 years or older have access to 214 similar studies."

Answered by AI

Has the FDA sanctioned Alcohol Administration - Late Luteal Phase?

"The team at Power assess the safety of Alcohol Administration - Late Luteal Phase to be a 3, recognizing that this is a phase 3 trial with evidence backing its efficacy and multiple confirmations of its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Sex Hormones and Alcohol on Sleep

Lauren Whitehurst 2024. "The Effects of Sex Hormones and Alcohol on Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06143059.