Estradiol and Fear Extinction in Anorexia Nervosa (AN)

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Drug: Estradiol

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Estrogen; AN participants receive a course of transdermal estradiol treatment.	Drug: Estradiol; 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.; Other Names: Climara

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Angela Guarda, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ACTUAL): August 22, 2018
• Study Completion (ACTUAL): August 22, 2018

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (ESTIMATE): June 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: estrogen; anxiety; amenorrhea; eating disorders
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estradiol
• Other Study ID Numbers: IRB00030009