Estradiol Effects on Alcohol Across the Menstrual Cycle

Sponsor

Mark Fillmore (Other)

Overall Status

Recruiting

CT.gov ID

NCT04595682

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

100

Enrollment

Location

Arm

54.5

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use, Unspecified	Drug: Placebo Drug: Alcohol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Sep 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Kentucky Psychology Research Lab	Lexington	Kentucky	United States	40504

Sponsors and Collaborators

Mark Fillmore
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Mark Fillmore, PhD, University of Kentucky
Principal Investigator: Michelle Martel, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mark Fillmore, Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT04595682

Other Study ID Numbers:

52637
1R01AA027990-01A1

First Posted:

Oct 20, 2020

Last Update Posted:

Sep 9, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Mark Fillmore, Professor, University of Kentucky

Additional relevant MeSH terms:

Alcohol Drinking

Study Results

No Results Posted as of Sep 9, 2021