Clinical trial NCT02792153: Estradiol and Fear Extinction in Anorexia Nervosa (AN)
Official title: Estradiol and Fear Extinction for Calorie-Dense Foods in Weight Restored Adult Women With Anorexia Nervosa (AN)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Anorexia Nervosa
Keywords: estrogen
anxiety
amenorrhea
eating disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Electrodermal skin conductance activity (EDA) during a test meal
timeFrame: Baseline (day 1) and post-treatment (day 21)
Secondary outcomes:
measure: Heart rate variability during a test meal
timeFrame: Baseline (day 1) and post-treatment (day 21)
measure: Subjective ratings of anxiety
timeFrame: Baseline (day 1) and post-treatment (day 21)
measure: Salivary cortisol concentration during a test meal
timeFrame: Baseline (day 1) and post-treatment (day 21)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Angela Guarda, MD
role: PRINCIPAL_INVESTIGATOR
References: