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Completed

NCT Number: NCT04595682

Estradiol Effects on 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.

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Key information

Conditions

Alcohol Use, Unspecified Alcohol Drinking Behavior Drinking Behavior

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Of Kentucky Psychology Research Lab

Lexington, Kentucky, 40504, United States

About this study

A longitudinal study design will test hormonal influences across the menstrual cycle on women's naturalistic drinking behavior, as well as their acute sensitivity to the rewarding and disinhibiting effects of alcohol in the laboratory, two key mechanisms of its abuse potential. Subjects will attend a diagnostic visit to assess baseline clinical characteristics. In addition, subjects will attend two laboratory visits to test alcohol sensitivity at two key points in the cycle: during the early follicular phase when E2 is low and the late follicular phase when E2 is rising (see Figure 6). Every day after their first laboratory visit for 35 consecutive days, women will provide saliva samples each morning to assess hormonal levels and complete a self-report on their drinking behavior and alcohol craving every evening through a secure online server. The daily saliva and self-report data will allow fine-grained investigation of the lagged correlations between E2 and daily alcohol use patterns and alcohol craving across the menstrual cycle. The two laboratory visits will test and compare the acute sensitivity to rewarding and disinhibiting effects of a controlled dose of alcohol during the early follicular phase when E2 is low and the late follicular phase when E2 is rising. Volunteers will be followed daily to assess when they start their next menstrual cycle (i.e., the day they start bleeding). Within 1-2 days of that point, volunteers are scheduled to attend their initial diagnostic visit. Participants are then counterbalanced to begin the study during either their early follicular phase (approximately day 5) or their late follicular phase (approximately day 12) which is also when they begin their 35 days of consecutive daily data collection. This serves to counterbalance the order of the two alcohol sensitivity test sessions: early follicular versus late follicular phase. Ovulation testing and daily salivary E2 will confirm the proximity of the late follicular phase to ovulation, with the goal of ovulation occurring 1-3 days after the late follicular visit, and capturing a higher, rising E2 level in the late follicular phase relative to a lower level in the early follicular phase.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

Drug

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 outcomes

  1. Attentional Bias (Early Follicular Phase)

    Time frame: 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 is measured. Subjects look at images on a screen and their attention to various images is measured. An alcohol-related image and a neutral control image are presented briefly side-by-side, on a computer screen. An eye tracker embedded into the monitor provides an unobtrusive measure of the duration (dwell time) that volunteers look at each image.

  2. Attentional Bias (Late Follicular Phase)

    Time frame: 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 is measured. Subjects look at images on a screen and their attention to various images is measured. An alcohol-related image and a neutral control image are presented briefly side-by-side, on a computer screen. An eye tracker embedded into the monitor provides an unobtrusive measure of the duration (dwell time) that volunteers look at each image.

  3. Disinhibition (Early Follicular Phase)

    Time frame: 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. Participants complete 250 trials in which they are presented with a cue, followed by a target. A go target is green, and participants are instructed to press a button when presented with a go target. A no-go target is blue, and participants are instructed to do nothing when this appears.

    A go cue predicts a go target with 80% accuracy, whereas a no-go cue predicts a no-go target with 80% accuracy.

    The condition of interest is when a go cue is followed by a no-go target. The proportion reported is the proportion of trials under this condition in which participants press the button (expecting a go target but presented with a no-go target).

  4. Disinhibition (Late Follicular Phase)

    Time frame: 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. Participants complete 250 trials in which they are presented with a cue, followed by a target. A go target is green, and participants are instructed to press a button when presented with a go target. A no-go target is blue, and participants are instructed to do nothing when this appears.

    A go cue predicts a go target with 80% accuracy, whereas a no-go cue predicts a no-go target with 80% accuracy.

    The condition of interest is when a go cue is followed by a no-go target. The proportion reported is the proportion of trials under this condition in which participants press the button (expecting a go target but presented with a no-go target).

  5. Subjective Ratings of the Rewarding Effects of Alcohol (Early Follicular Phase)

    Time frame: 1 day

    a visual analog scale from 0-100, with 0 being not rewarding at all and 100 being very rewarding

  6. Subjective Ratings of the Rewarding Effects of Alcohol (Late Follicular Phase)

    Time frame: 1 day

    a visual analog scale from 0-100, with 0 being not rewarding at all and 100 being very rewarding

Sponsors and collaborators

Lead sponsor

Mark Fillmore

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2020
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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