Trial Outcomes & Findings for Estradiol Effects on Alcohol Across the Menstrual Cycle (NCT NCT04595682)
NCT ID: NCT04595682
Last Updated: 2025-08-22
Results Overview
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.
COMPLETED
NA
100 participants
1 day
2025-08-22
Participant Flow
For this study participants are randomly started in Late Follicular Phase (Day 12) or Early Follicular Phase (Day 5) based on when they are enrolled in the study and which day of their menstrual cycle they are on when enrolled. This order does not affect the treatment given to each participant in any way. Every participant is given a placebo, then alcohol.
Participant milestones
| Measure |
Late Follicular Phase Visit First, Then Early Follicular Phase Visit
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).
beginning the study during their late follicular phase (approximately day 12) which is also when they begin their 35 days of consecutive daily data collection
|
Early Follicular Phase Visit First, Then Late Follicular Phase Visit
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).
beginning the study during their early follicular phase (approximately day 5) which is also when they begin their 35 days of consecutive daily data collection
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|---|---|---|
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Overall Study
STARTED
|
45
|
55
|
|
Overall Study
COMPLETED
|
45
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Estradiol Effects on Alcohol Across the Menstrual Cycle
Baseline characteristics by cohort
| Measure |
Study Participants
n=100 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).
|
|---|---|
|
Age, Continuous
|
23.98 years
STANDARD_DEVIATION 3.47 • n=99 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
100 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 dayAttentional 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.
Outcome measures
| Measure |
Study Participants
n=100 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).
|
|---|---|
|
Attentional Bias (Early Follicular Phase)
Alcohol
|
347.99 milliseconds
Standard Deviation 51.61
|
|
Attentional Bias (Early Follicular Phase)
Placebo
|
355.02 milliseconds
Standard Deviation 56.02
|
PRIMARY outcome
Timeframe: 1 dayAttentional 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.
Outcome measures
| Measure |
Study Participants
n=100 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).
|
|---|---|
|
Attentional Bias (Late Follicular Phase)
Alcohol
|
356.01 milliseconds
Standard Deviation 57.58
|
|
Attentional Bias (Late Follicular Phase)
Placebo
|
352.81 milliseconds
Standard Deviation 57.14
|
PRIMARY outcome
Timeframe: 1 dayDisinhibition 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).
Outcome measures
| Measure |
Study Participants
n=100 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).
|
|---|---|
|
Disinhibition (Early Follicular Phase)
Alcohol
|
0.107 proportion of inhibition failures
Standard Deviation 0.12
|
|
Disinhibition (Early Follicular Phase)
Placebo
|
0.04 proportion of inhibition failures
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 1 dayDisinhibition 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).
Outcome measures
| Measure |
Study Participants
n=100 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).
|
|---|---|
|
Disinhibition (Late Follicular Phase)
Placebo
|
0.045 proportion of inhibition failures
Standard Deviation 0.06
|
|
Disinhibition (Late Follicular Phase)
Alcohol
|
0.134 proportion of inhibition failures
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: 1 daya visual analog scale from 0-100, with 0 being not rewarding at all and 100 being very rewarding
Outcome measures
| Measure |
Study Participants
n=100 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).
|
|---|---|
|
Subjective Ratings of the Rewarding Effects of Alcohol (Early Follicular Phase)
Alcohol
|
56.99 score on a scale
Standard Deviation 25.61
|
|
Subjective Ratings of the Rewarding Effects of Alcohol (Early Follicular Phase)
Placebo
|
39.2 score on a scale
Standard Deviation 23.26
|
PRIMARY outcome
Timeframe: 1 daya visual analog scale from 0-100, with 0 being not rewarding at all and 100 being very rewarding
Outcome measures
| Measure |
Study Participants
n=100 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).
|
|---|---|
|
Subjective Ratings of the Rewarding Effects of Alcohol (Late Follicular Phase)
Alcohol
|
60.17 score on a scale
Standard Deviation 22.23
|
|
Subjective Ratings of the Rewarding Effects of Alcohol (Late Follicular Phase)
Placebo
|
39.43 score on a scale
Standard Deviation 22.37
|
Adverse Events
Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place