Estradiol and Fear Extinction in Anorexia Nervosa (AN)

Anorexia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02792153
• Other study ID #: IRB00030009
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 2016
• Est. completion date: August 22, 2018

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)