Estradiol Effects on Alcohol Across the Menstrual Cycle

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use, Unspecified

Intervention / Treatment
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* Drug: Placebo
* Drug: Alcohol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Participants<br>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). | Drug: Placebo<br>* 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.<br>Drug: Alcohol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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estradiol, reward, menstrual, hormone