Binge Eating & Birth Control

University of North Carolina (UNC)

Status and phase

Terminated

Phase 2

Conditions

Binge-Eating Disorder

Bulimia Nervosa

Eating Disorders

Binge Eating

Treatments

Drug: Drospirenone-Ethinyl Estradiol Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04278755

19-3149

Details and patient eligibility

About

This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for three months. Prior to medication administration and at the end of treatment, eating behaviors will be measured and fMRI will be conducted in order to examine changes in activation in dopamine-reward pathways that occur with oral contraceptive administration. This will assess changes in brain activation that occur with the stabilization of ovarian hormones.

Full description

Eating disorders (EDs) affect 15 million women in the United States and have one of the highest mortality rates of any mental illness. Despite this, the underlying neurobiology remains poorly understood. EDs predominantly occur in women, and the frequency of certain symptoms change in a predictable pattern over the menstrual cycle; specifically, symptom changes appear to be triggered by normal fluctuations in the ovarian hormones estradiol (E2) and progesterone (P4).

The objective of this study is to examine the impact of ovarian hormone stabilization, through the continuous administration of oral contraceptives (OCs) for 3-months, on brain activation in response to reward and eating behaviors in women who binge eat (n=15) using functional magnetic resonance imaging (fMRI) and behavioral testing. OCs work by suppressing ovulation, thereby reducing E2 and P4 changes that occur pre- and post- ovulation. Because the traditional 21/7 regimen of OC administration (21 active pills followed by 7 days of inactive pills) allows follicles to begin to develop, this leads to the secretion of endogenous E2, and then E2 withdrawal once active pills begin again. This does not result in consistent stabilization. Thus, this study will use OCs in a continuous manner, with no inactive pills.

Participants will complete fMRI imaging and self-report questionnaires prior to OC administration and at the end of OC administration. The investigators will examine within-subject changes that occur in these measures with OC administration. The primary hypothesis is that continuous OC treatment will have a beneficial/stabilizing effect on outcomes of interest. Specifically, symptomatology may decrease from OC use. Results will ultimately provide the pilot data necessary for larger mechanistic trials.

The specific aims are to:

Aim 1: Quantify the effect of ovarian hormone stabilization on eating behaviors in women with binge eating.

Aim 2: Examine the effect of ovarian hormone stabilization on response to reward using fMRI and self-report questionnaires in women with binge eating.

Enrollment

8 patients

Sex

Female

Ages

18 to 34 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Participants will include women ages 18-34 with a current Diagnostic and Statistical Manual (DSM-5) diagnosis of a binge eating syndrome and a regular menstrual cycle. Only participants capable of giving informed consent and understanding the risks associated with the study will be enrolled.

Current binge eating behaviors meeting DSM-5 criteria for a binge eating syndrome
Age 18-34
Regular menstrual cycle for at least 3-months
Free of medication or medical condition that impacts ovarian hormones or is contraindicated for use with study interventions (including birth control)
Speaks English

Exclusion Criteria

any foreign metal objects or implants in your body as determined by the safety questionnaires (due to fMRI)
use of birth control or hormones in the past 3-months
hormonal contraceptives that are implanted (i.e. progestin intrauterine device or implant)
current pregnancy, lactation, or < 12-weeks postpartum
previous serious, negative reaction to birth control
current smoker
< 18.5 BMI > 31
history of bipolar disorder or psychotic episodes
frequent laxative and/or diuretic use
previous suicide attempt
abnormal/undiagnosed vaginal bleeding; endometriosis
recurrent migraine headaches or headaches with focal neurological symptoms
hypertension or vascular disease (i.e., coronary artery disease, congestive heart failure, cerebrovascular disease)
diabetes or other circulation problems
blood clotting disorder
porphyria
breast, uterus/cervix, or vaginal cancer
medical condition or medication use that increases serum potassium levels (including frequent laxative or diuretic use)
high cholesterol
history of venous thromboembolus (VTE), deep vein thrombosis, pulmonary embolism, phlebothrombosis, coronary thrombosis, thromboembolism, thrombophlebitis, or any type of blood clot or blood clot disorder (e.g., thromboembolic disease, Factor V Leiden), protein C or S deficiency, heart attack or stroke, atrial fibrillation, heart, liver, kidney, or adrenal disease, endocarditis, liver cancer, malignant melanoma, cholecystitis or pancreatitis, VTE or jaundice caused by pregnancy or birth control pills, recent significant period of immobility (e.g., pregnancy bed rest), immediate family history of a hereditary blood clotting disorder
Pregnant women will be excluded from participation and women who become pregnant (although unlikely) will be withdrawn. Prior to enrollment, a pregnancy test will be completed. All participants will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study. If a woman becomes pregnant during the study, participation will be discontinued.
Any condition or symptoms considered by the study team to detrimentally impact subject safety.