Binge Eating & Birth Control

NCT ID: NCT04278755

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2022-05-17

Brief Summary

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.

Detailed 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.

Conditions

Bulimia Nervosa; Binge Eating; Eating Disorders; Binge-Eating Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Continuous OC

Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).

Group Type: EXPERIMENTAL

Drospirenone-Ethinyl Estradiol Oral Tablet

Intervention Type: DRUG

3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.

Interventions

Drospirenone-Ethinyl Estradiol Oral Tablet

3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.

Intervention Type: DRUG

Other Intervention Names

Yasmin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Foundation of Hope, North Carolina

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Baker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-3149

Identifier Type: -

Identifier Source: org_study_id