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Estradiol Effects on Alcohol Across the Menstrual Cycle

Primary Purpose

Alcohol Use, Unspecified

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Alcohol
Sponsored by
Mark Fillmore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use, Unspecified focused on measuring estradiol, reward, menstrual, hormone

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Of Kentucky Psychology Research LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Participants

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2020
Last Updated
September 8, 2023
Sponsor
Mark Fillmore
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04595682
Brief Title
Estradiol Effects on Alcohol Across the Menstrual Cycle
Official Title
Estradiol Effects on Behavioral and Reward Sensitivity to Alcohol Across the Menstrual Cycle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Fillmore
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified
Keywords
estradiol, reward, menstrual, hormone

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Participants
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attentional Bias (Early Follicular Phase)
Description
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.
Time Frame
1 day
Title
Attentional Bias (Late Follicular Phase)
Description
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.
Time Frame
1 day
Title
Disinhibition (Early Follicular Phase)
Description
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.
Time Frame
1 day
Title
Disinhibition (Late Follicular Phase)
Description
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.
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
8592575794
Email
psychresearch@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Fillmore, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Martel, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Kentucky Psychology Research Lab
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-257-5794
Email
psychresearch@uky.edu
First Name & Middle Initial & Last Name & Degree
Mark Fillmore, PhD
First Name & Middle Initial & Last Name & Degree
Michelle Martel, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36265052
Citation
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.
Results Reference
derived

Learn more about this trial

Estradiol Effects on Alcohol Across the Menstrual Cycle

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