Estradiol Effects on Alcohol Across the Menstrual Cycle

Alcohol Use, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595682
• Other study ID #: 52637
• Secondary ID: 1R01AA027990-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2023
• Source: University of Kentucky
• Contact: Study Coordinator
• Phone: 8592575794
• Email: psychresearch[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University Of Kentucky Psychology Research Lab	Lexington	Kentucky

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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