Exploring how sex differences and hormones affect alcohol use disorder risk
Sex Differences in Risk for Alcohol Use Disorder: Neural and Hormonal Influences
This study is trying to see how differences between men and women, along with hormones, affect the risk of developing alcohol use disorder, especially in women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 26 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04929288 on ClinicalTrials.gov |
What this trial studies
This study investigates the factors contributing to the increasing rates of Alcohol Use Disorder (AUD) among women, particularly focusing on sex differences in risk factors such as executive function, negative emotionality, and incentive salience. It aims to understand how poor inhibitory control, which is more pronounced in women, and hormonal influences, particularly estradiol, affect these risk factors. Participants will undergo assessments related to their alcohol consumption and brain activity using fMRI to identify the neural mechanisms involved. The study seeks to provide insights that could lead to tailored interventions for AUD based on sex-specific risk factors.
Who should consider this trial
Good fit: Ideal candidates are women who consume 4-5 alcoholic drinks per week, are fluent in English, and have regular menstrual cycles.
Not a fit: Patients with serious medical issues, other substance use disorders, or those who are pregnant or on hormonal contraception may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, sex-specific prevention and treatment strategies for Alcohol Use Disorder.
How similar studies have performed: Other studies have shown success in exploring sex differences in addiction, but this specific approach focusing on hormonal influences and executive function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * consume 4/5 drinks per week * fluent in English * high school education * right-handed * regular menstrual cycles (women) Exclusion Criteria: * serious medical problems * body weight \<110 or \>210 lbs * current medical or psychiatric conditions requiring medication for which alcohol is contraindicated * substance use disorder other than alcohol * current or recent history of inpatient/intensive treatment for addictive behaviors * pregnant, nursing, on hormonal contraception * contraindications for fMRI * smoking \> 5 cigarettes per day
Where this trial is running
Columbus, Ohio
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Weafer, PhD — Ohio State University
- Study coordinator: Jessica Weafer, PhD
- Email: Jessica.Weafer@osumc.edu
- Phone: 614-366-0163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.