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Alcohol for Alcoholism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
AlcoholismAlcohol - Drug
Eligibility
21 - 26
All Sexes
What conditions do you have?
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Study 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).

Eligible Conditions
  • Alcoholism

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Alcohol
1
Suvorexant Treatment
1
Alcohol

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: 18 months

12 minutes
Neural alcohol cue reactivity
13 minutes
Neural inhibitory function
14 minutes
Neural negative emotionality
18 months
Prospective alcohol consumption
20 minutes
Self-reported current alcohol consumption
60 minutes
Ethanol

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Alcohol
1
Suvorexant Treatment
1
Alcohol

Side Effects for

Ghrelin
59%Increased Appetite
41%Somnolence
35%Euphoric mood
29%Fatigue
12%Hyperhidrosis
12%Memory impairment
12%Nausea
12%Dizziness
6%Decreased appetite
6%Flushing
6%Feeling hot
6%Headache
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT01779024) in the Ghrelin ARM group. Side effects include: Increased Appetite with 59%, Somnolence with 41%, Euphoric mood with 35%, Fatigue with 29%, Hyperhidrosis with 12%.

Trial Design

2 Treatment Groups

Females
1 of 2
Males
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Alcohol · No Placebo Group · N/A

Females
Drug
Experimental Group · 1 Intervention: Alcohol · Intervention Types: Drug
Males
Drug
Experimental Group · 1 Intervention: Alcohol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

Jessica WeaferLead Sponsor
3 Previous Clinical Trials
231 Total Patients Enrolled
3 Trials studying Alcoholism
231 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
719 Previous Clinical Trials
1,174,041 Total Patients Enrolled
377 Trials studying Alcoholism
976,563 Patients Enrolled for Alcoholism
Jessica Weafer, PhDPrincipal Investigator - University of Kentucky
University of Kentucky
2 Previous Clinical Trials
171 Total Patients Enrolled
2 Trials studying Alcoholism
171 Patients Enrolled for Alcoholism

Eligibility Criteria

Age 21 - 26 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Consume four out of five drinks per week.
I am fluent in English.
High school education is a requirement for most jobs
You are right-handed.
A woman's regular menstrual cycles are a result of the body's normal hormone production.
References

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