Estradiol Effects on Alcohol Across the Menstrual Cycle

NCT04595682 | Completed Results

• 2 other identifiers: 526371R01AA027990-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide the first rigorous integrative test of the hypothesis that rapid rises in estradiol (a female hormone) increase the rewarding and disinhibiting effects of alcohol and that such increased sensitivity correlates with increased alcohol use. Identification of the behavioral mechanisms by which estradiol surges can increase alcohol use would provide a critical advancement of neurobiological theory of alcohol abuse in women, an understudied area, as well as provide new directions for personalization of alcohol abuse treatment in women. In this study, naturally-cycling women will be examined daily over their menstrual cycle using an integrative combination of daily ecological assessments of hormone fluctuations and alcohol use along with strategically-timed laboratory tests of their acute sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol.

Conditions

Alcohol Use, Unspecified

Keywords

estradiol; reward; menstrual; hormone

Outcome Measures

Primary Outcomes (6)

• Attentional Bias (Early Follicular Phase)

  Attentional bias is measured by the visual dot-probe task and provides an implicit assessment of the rewarding properties of alcohol as indicated by the degree to which an acute dose of alcohol increases the drinker's attention to alcohol cues is measured. Subjects look at images on a screen and their attention to various images is measured. An alcohol-related image and a neutral control image are presented briefly side-by-side, on a computer screen. An eye tracker embedded into the monitor provides an unobtrusive measure of the duration (dwell time) that volunteers look at each image.

  1 day

• Attentional Bias (Late Follicular Phase)

  Attentional bias is measured by the visual dot-probe task and provides an implicit assessment of the rewarding properties of alcohol as indicated by the degree to which an acute dose of alcohol increases the drinker's attention to alcohol cues is measured. Subjects look at images on a screen and their attention to various images is measured. An alcohol-related image and a neutral control image are presented briefly side-by-side, on a computer screen. An eye tracker embedded into the monitor provides an unobtrusive measure of the duration (dwell time) that volunteers look at each image.

  1 day

• Disinhibition (Early Follicular Phase)

  Disinhibition wil be measured by the cued go/no-go task, which requires participants to respond quickly to go targets and inhibit responses to no-go targets. Participants complete 250 trials in which they are presented with a cue, followed by a target. A go target is green, and participants are instructed to press a button when presented with a go target. A no-go target is blue, and participants are instructed to do nothing when this appears. A go cue predicts a go target with 80% accuracy, whereas a no-go cue predicts a no-go target with 80% accuracy. The condition of interest is when a go cue is followed by a no-go target. The proportion reported is the proportion of trials under this condition in which participants press the button (expecting a go target but presented with a no-go target).

  1 day

• Disinhibition (Late Follicular Phase)

  Disinhibition wil be measured by the cued go/no-go task, which requires participants to respond quickly to go targets and inhibit responses to no-go targets. Participants complete 250 trials in which they are presented with a cue, followed by a target. A go target is green, and participants are instructed to press a button when presented with a go target. A no-go target is blue, and participants are instructed to do nothing when this appears. A go cue predicts a go target with 80% accuracy, whereas a no-go cue predicts a no-go target with 80% accuracy. The condition of interest is when a go cue is followed by a no-go target. The proportion reported is the proportion of trials under this condition in which participants press the button (expecting a go target but presented with a no-go target).

  1 day

• Subjective Ratings of the Rewarding Effects of Alcohol (Early Follicular Phase)

  a visual analog scale from 0-100, with 0 being not rewarding at all and 100 being very rewarding

  1 day

• Subjective Ratings of the Rewarding Effects of Alcohol (Late Follicular Phase)

  a visual analog scale from 0-100, with 0 being not rewarding at all and 100 being very rewarding

  1 day

Study Arms (1)

menstrual cycle

EXPERIMENTAL

Participants will have their alcohol sensitivity test once during their early follicular phase and once during their late follicular phase

Drug: Placebo; Drug: Alcohol

Interventions

Placebo DRUG

Participants will attend two identical laboratory sessions to test sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol, once during the early follicular phase and once during the late follicular phase. The test battery consists of measures of rewarding effects and alcohol (or placebo) effects on disinhibition and impulsive choice. The placebo consists of 300 ml of lemon-flavored soda with a small amount (3 ml) of alcohol floated on top.

menstrual cycle

Alcohol DRUG

Participants will attend two identical laboratory sessions to test sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol, once during the early follicular phase and once during the late follicular phase. The test battery consists of measures of rewarding effects and alcohol effects on disinhibition and impulsive choice. The alcohol dose consists of 0.60 g/kg absolute alcohol that produces a peak blood-alcohol concentration of 80 mg/dl. Doses will be mixed with a carbonated, non-caffeinated, lemon-flavored soda and consumed within 10 minutes.

menstrual cycle

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• regular menstrual cycle
• consume alcohol at least once per week
• no history of drug or alcohol dependence

You may not qualify if:

• use of hormone-based medications
• irregular menstrual cycle
• current pregnancy
• primary sensorimotor handicap
• frank neurological disorder
• pervasive developmental disorder
• frank psychosis
• diagnosed intellectual disability
• medical condition contraindicating alcohol use
• substance abuse history (except nicotine)
• body mass index (BMI) 30 or above
• alcohol abstainer

Sponsors & Collaborators

• Mark Fillmore: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University Of Kentucky Psychology Research Lab

Lexington, Kentucky, 40504, United States

Location

Related Publications (2)

• Griffith AK, Martel MM, Fillmore MT. Effect of menstrual cycle on rewarding properties of alcohol cues in women. Psychol Addict Behav. 2024 Sep;38(6):676-687. doi: 10.1037/adb0000978. Epub 2023 Dec 7.

  PMID: 38059946 DERIVED

• Griffith AK, Martel MM, Eisenlohr-Moul T, Fillmore MT. Heightened sensitivity to the disinhibiting effect of alcohol in women during the late follicular phase of the menstrual cycle. Exp Clin Psychopharmacol. 2023 Aug;31(4):839-848. doi: 10.1037/pha0000611. Epub 2022 Oct 20.

  PMID: 36265052 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr. Mark Fillmore
• Organization: University of Kentucky

fillmore@uky.edu

8592574728

Study Officials

• Mark Fillmore, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Michelle Martel, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: March 15, 2021
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)