← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am female.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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%

Memory impairment

12%

Hyperhidrosis

12%

Dizziness

12%

Nausea

Feeling hot

Flushing

Headache

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Ghrelin

Placebo

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mark FillmoreLead Sponsor

2 Previous Clinical Trials

142 Total Patients Enrolled

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

800 Previous Clinical Trials

1,362,897 Total Patients Enrolled

Mark Fillmore, PhDPrincipal Investigator - University of Kentucky

University of Kentucky

1 Previous Clinical Trials

120 Total Patients Enrolled

Media Library

Estradiol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04595682 — N/A

Estradiol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04595682 — N/A

Alcohol Use Disorder Research Study Groups: Study Participants

Alcohol Use Disorder Clinical Trial 2023: Estradiol Highlights & Side Effects. Trial Name: NCT04595682 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions is ethanol regularly utilized to address?

"Alcohol is typically utilized to cure obstructive hypertrophic cardiomyopathy. Additionally, it may be advantageous for the treatment of communicable diseases, ethylene glycol poisoning, and disinfection therapy of skin lesions."

Answered by AI

Is this investigation open to people aged forty or older?

"As articulated in the enrollment specifications, applicants between 21 and 35 years of age are qualified to participate."

Answered by AI

How many people are currently participating in this experiment?

"Affirmative. According to clinicaltrials.gov, this research project which was introduced on March 15th 2021 is currently open for enrollment and recently updated in September 25th 2022. The clinical trial will include 100 individuals from a single location."

Answered by AI

Are applications currently being accepted to join this research?

"Correct. Clinicaltrials.gov confirms that this medical trial, initially posted on March 15th 2021, is still recruiting patients. The study was last revised on September 25th 2022."

Answered by AI

Can I enroll in this clinical research initiative?

"This scientific trial is recruiting 100 people with alcohol use disorder aged between 21 and 35. Female participants, who experience regular menstrual cycles and consume alcoholic beverages at least weekly while not having a history of substance dependency, are particularly encouraged to apply."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Estradiol Effects on Alcohol Across the Menstrual Cycle

Mark Fillmore 2021. "Estradiol Effects on Alcohol Across the Menstrual Cycle". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04595682.

All > Acth