Binge Eating & Birth Control
Condition: Bulimia Nervosa; Binge Eating; Eating Disorders; Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Intervention: Drospirenone-Ethinyl Estradiol Oral Tablet
Intervention description: 3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
Intervention MeSH terms: Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: No

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.
    

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.