Estradiol and Fear Extinction in Anorexia Nervosa (AN)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether estrogen may help reduce fear of high calorie-density foods in weight-restored women with Anorexia Nervosa (AN).

Official Title
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Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Drug: Estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (AN): Previous diagnosis of recent AN with BMI of <18.5 (within past year) Current BMI > 19.0 and < 23.0 kg/m2 Amenorrhea or oligomenorrhea Inclusion Criteria (Healthy Controls): BMI > 19 < 23 kg/m2 Taking hormone-based contraceptives for a period of one month or more Eating disorders symptom scores within one standard deviation of healthy controls Exclusion Criteria (AN): Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality History of breast cancer, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke, diabetes, liver disease, known thrombophilic disease Currently taking estrogen or progesterone medication Tobacco use greater than 1 pack per week Use of St. John's Wort, Phenobarbital, phenytoin, carbamazepine, rifampin, and dexamethasone can all decrease plasma estrogen level because they are CYP3A4 inducers. Cimetidine, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice as these may increase plasma estrogen, potentially increasing the presence of side effects Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks) Allergy to estradiol or medroxyprogesterone or ingredients in food items used for test meals Undiagnosed, abnormal vaginal bleeding Exclusion Criteria (Healthy Controls): Ever diagnosed with an Eating Disorder Any medical or psychiatric problem requiring urgent medical or psychiatric attention, including acute suicidality Pregnant, lactating or unwilling to use appropriate birth control (which may include abstinence) to prevent pregnancy for the duration of study participation (i.e. up to 4 weeks) Food allergies to items in the test meal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estrogen<br>AN participants receive a course of transdermal estradiol treatment. | Drug: Estradiol<br>* AN participants will be prescribed 28 days of transdermal estradiol 0.1 mg/d (Days 1-28) plus 10 days (days 21-31) oral medroxyprogesterone 2.5 mg/d.<br>* Other names: Climara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrodermal skin conductance activity (EDA) during a test meal | Meal-related anxiety will be estimated from EDA recordings during a 90 minute test meal session pre- and post-treatment (day 1 and day 21). EDA will be reported as the rate of peaks (>0.02 microsiemens) per second and the average skin conductance level (in microsiemens). | Baseline (day 1) and post-treatment (day 21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability during a test meal | Variability in heart rate will be measured by the variation in interpeak (beat-to-beat) interval during the 90 minute test meal session pre- and post- treatment (day 1 and day 21). | Baseline (day 1) and post-treatment (day 21) | 
| Subjective ratings of anxiety | Visual analog scales will be used to assess self-report anxiety at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the 90 minute test meal session pre- and post-treatment (day 1 and day 21). | Baseline (day 1) and post-treatment (day 21) | 
| Salivary cortisol concentration during a test meal | The concentration of salivary cortisol will be assessed at multiple points (time 0 min, 5 min, 10 min, 20 min, 30 min, 50 min, 70 min and 90 min) during the test meal session. Test meals occur twice during the entire length of the study on day 1 and day 21. The cortisol response will be reported as area under the curve. | Baseline (day 1) and post-treatment (day 21) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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estrogen, anxiety, amenorrhea, eating disorders