Status:
RECRUITING
The Effects of Sex Hormones and Alcohol on Sleep
Lead Sponsor:
Lauren Whitehurst
Collaborating Sponsors:
Ohio State University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-45 years
Phase:
PHASE3
Brief 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. Numerous studie...
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. Unfort...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06143059
Start Date
January 8 2024
End Date
November 1 2028
Last Update
February 5 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40508