Estradiol and Fear Extinction in Anorexia Nervosa (AN)

Johns Hopkins University

Status and phase

Withdrawn

Phase 1

Conditions

Anorexia Nervosa

Treatments

Drug: Estradiol

Study type

Interventional

Funder types

Other

Identifiers

NCT02792153

IRB00030009

Details and patient eligibility

About

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).

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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