NCT04929288 Neural and Hormonal Influences on Sex Differences in Risk for AUD
| NCT ID | NCT04929288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jessica Weafer |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-05-11 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-05-11 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The sex gap in alcohol consumption is closing rapidly, due to alarming increases among women. From 2002-2013, Alcohol Use Disorder (AUD) increased 84% for women, compared to 35% for men. As such, there is an urgent need to determine the factors underlying sex differences in risk for AUD. Current addiction models propose three domains that drive problematic alcohol use and serve as candidate sex-specific risk factors: executive function, negative emotionality, and incentive salience. Data suggest that poor inhibitory control, a key component of executive function, is a stronger risk factor for women than for men. Moreover, there is have preliminary evidence that female drinkers show less engagement of neural inhibitory circuitry, and that this sex difference is influenced by estradiol. However, the degree to which hormonally-moderated sex differences in executive function extend to the negative emotionality and incentive salience domains, and how these sex differences influence current and future drinking is unknown. The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment efforts. The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience).
Eligibility 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
Contact & Investigator
Jessica Weafer, PhD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT04929288 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 26 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04929288 currently recruiting?
Yes, NCT04929288 is actively recruiting participants. Contact the research team at Jessica.Weafer@osumc.edu for enrollment information.
Where is the NCT04929288 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT04929288 clinical trial?
NCT04929288 is sponsored by Jessica Weafer. The principal investigator is Jessica Weafer, PhD at Ohio State University. The trial plans to enroll 100 participants.