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Behavioural Intervention

Neural and Hormonal Influences on Alcohol Use Disorder Risk

N/A
Recruiting
Led By Jessica Weafer, PhD
Research Sponsored by Jessica Weafer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
regular menstrual cycles (women)
Be between 18 and 65 years old
Must not have
current medical or psychiatric conditions requiring medication for which alcohol is contraindicated
body weight <110 or >210 lbs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is looking at the neural and hormonal factors that contribute to why women are more at risk for AUD than men. They will be looking at three addiction domains: inhibitory control (executive function), negative emotionality, and alcohol cue reactivity (incentive salience).

Who is the study for?
This trial is for English-speaking, right-handed individuals with at least a high school education who regularly consume alcohol. Women must have regular menstrual cycles and not be pregnant, nursing, or on hormonal contraception. Participants should weigh between 110 and 210 lbs and not require medication that interacts badly with alcohol.
What is being tested?
The study aims to understand why women are increasingly at risk for Alcohol Use Disorder (AUD) by examining brain function and hormone levels related to self-control, emotional response, and reactions to alcohol cues.
What are the potential side effects?
Since the intervention involves consuming alcohol, potential side effects include typical acute effects of drinking such as impaired coordination, dizziness, nausea, vomiting, hangovers or more serious risks like addiction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have regular menstrual cycles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I take medication that shouldn't be mixed with alcohol due to my health condition.
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My weight is either below 110 lbs or above 210 lbs.
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I am not pregnant, nursing, or using hormonal birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ethanol
Neural alcohol cue reactivity
Neural inhibitory function
+3 more

Side effects data

From 2017 Phase 2 trial • 17 Patients • NCT01779024
59%
Increased Appetite
41%
Somnolence
35%
Euphoric mood
29%
Fatigue
12%
Hyperhidrosis
12%
Memory impairment
12%
Dizziness
12%
Nausea
6%
Feeling hot
6%
Flushing
6%
Headache
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ghrelin
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MalesExperimental Treatment1 Intervention
Participants in this group will be adult male drinkers.
Group II: FemalesExperimental Treatment1 Intervention
Participants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
FDA approved

Find a Location

Who is running the clinical trial?

Jessica WeaferLead Sponsor
4 Previous Clinical Trials
462 Total Patients Enrolled
4 Trials studying Alcoholism
462 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
839 Previous Clinical Trials
1,083,548 Total Patients Enrolled
459 Trials studying Alcoholism
823,731 Patients Enrolled for Alcoholism
Jessica Weafer, PhDPrincipal Investigator - Ohio State University
University of Kentucky
3 Previous Clinical Trials
434 Total Patients Enrolled
3 Trials studying Alcoholism
434 Patients Enrolled for Alcoholism

Media Library

Neural and Hormonal Influences on Sex Differences in Risk for AUD (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04929288 — N/A
Alcoholism Research Study Groups: Males, Females
Alcoholism Clinical Trial 2023: Neural and Hormonal Influences on Sex Differences in Risk for AUD Highlights & Side Effects. Trial Name: NCT04929288 — N/A
Neural and Hormonal Influences on Sex Differences in Risk for AUD (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929288 — N/A
~12 spots leftby Jun 2025
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