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Hormone Therapy

Hormonal Effects on Alcohol Use

N/A

Recruiting

Led By Mark Fillmore, PhD

Research Sponsored by Mark Fillmore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Be between 18 and 65 years old

Must not have

Medical condition contraindicating alcohol use

Use of hormone-based medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial will study how female hormones may impact alcohol use and abuse.

Who is the study for?

This trial is for women with regular menstrual cycles who drink alcohol at least once a week. They must not be pregnant, have a BMI of 30 or above, use hormone-based medications, or have any history of substance abuse (except nicotine) or certain medical and psychological conditions.

What is being tested?

The study investigates how estradiol (a female hormone) affects the rewarding and disinhibiting effects of alcohol during different phases of the menstrual cycle. It involves daily monitoring and lab tests to see if changes in estradiol levels influence alcohol consumption.

What are the potential side effects?

Since this trial involves consuming alcohol under controlled conditions, potential side effects may include typical reactions to alcohol such as dizziness, nausea, impaired coordination, mood changes, and intoxication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health condition that prevents me from drinking alcohol.

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I am currently taking hormone-based medications.

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I have a diagnosed neurological disorder.

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I have a major difficulty with movement or sensation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attentional Bias (Early Follicular Phase)

Attentional Bias (Late Follicular Phase)

Disinhibition (Early Follicular Phase)

+1 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

Feeling hot

Flushing

Headache

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Ghrelin

Placebo

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study ParticipantsExperimental Treatment2 Interventions

Participants in this group will track their menstrual cycle, provide daily saliva samples, and undergo two rounds of alcohol sensitivity testing (with both placebo and alcohol).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Ethanol

FDA approved

0 / 5Eligibility criteria met