Estradiol Effects on Alcohol Across the Menstrual Cycle

Estradiol Effects on Behavioral and Reward Sensitivity to Alcohol Across the Menstrual Cycle

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use, Unspecified
• Intervention / Treatment: Drug: Placebo; Drug: Alcohol

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 8592575794; Email: psychresearch@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Recruiting
      • University Of Kentucky Psychology Research Lab
      • Principal Investigator: Michelle Martel, PhD
      • Contact: Study Coordinator; Phone Number: 859-257-5794; Email: psychresearch@uky.edu
      • Principal Investigator: Mark Fillmore, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Participants; 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).

Drug: Placebo; 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.; Drug: Alcohol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	1 day

Collaborators and Investigators

• Sponsor: Mark Fillmore
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Michelle Martel, PhD, University of Kentucky; Principal Investigator: Mark Fillmore, PhD, University of Kentucky

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: estradiol; reward; hormone; menstrual
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 52637; 1R01AA027990-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes