Estradiol Effects on Alcohol Across the Menstrual Cycle

Not Applicable

Completed

• Conditions: Alcohol Use, Unspecified
• Interventions: Drug: Placebo; Drug: Alcohol

• Registration Number: NCT04595682
• Lead Sponsor: Mark Fillmore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2021-03-15
• Primary Completion: 2024-11-06
• Study Completion: 2024-11-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Participants	Placebo	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).
Study Participants	Alcohol	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).

Primary Outcome Measures

Name	Time	Method
Disinhibition (Early Follicular Phase)	1 day	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.
Attentional Bias (Early Follicular Phase)	1 day	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.
Disinhibition (Late Follicular Phase)	1 day	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.
Attentional Bias (Late Follicular Phase)	1 day	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.

Trial Locations

Locations (1)

University Of Kentucky Psychology Research Lab; 🇺🇸 Lexington, Kentucky, United States