N/A
N=100
Estradiol Effects on Alcohol Across the Menstrual Cycle
Alcohol Use, Unspecified
Bottom Line
View on ClinicalTrials.gov: NCT04595682 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Attentional Bias (Early Follicular Phase) — 347.99; 355.02 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Placebo (Drug); Alcohol (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Mark Fillmore
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attentional Bias (Early Follicular Phase) |
347.99; 355.02 | — |
| PRIMARY Attentional Bias (Late Follicular Phase) |
356.01; 352.81 | — |
| PRIMARY Disinhibition (Early Follicular Phase) |
0.107; 0.04 | — |
| PRIMARY Disinhibition (Late Follicular Phase) |
0.134; 0.045 | — |
| PRIMARY Subjective Ratings of the Rewarding Effects of Alcohol (Early Follicular Phase) |
56.99; 39.2 | — |
| PRIMARY Subjective Ratings of the Rewarding Effects of Alcohol (Late Follicular Phase) |
60.17; 39.43 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04595682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.