Neurobiology of Bulimia Nervosa
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Intervention: Estradiol; Micronized progesterone; Leuprolide Acetate; Placebo Oral Capsule
Intervention description: During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.; During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.; Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.; Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
Intervention MeSH terms: Leuprolide; Estradiol; Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 42 Years
Healthy volunteers: No
Keywords: bulimia nervosa; binge eating; eating disorder; estrogen

Summary:

      This pilot study experimentally manipulates ovarian hormones to examine the direct impact of
      estrogen (E2) and progesterone (P4) on binge eating symptom burden and the behavioral reward
      response in women with bulimia nervosa (n=15). This is completed by taking medications that
      change ovarian hormone levels. This line of research could lead to the development of
      pharmacological interventions developed to target specific areas of the brain, brain
      receptors, or pathways identified to be involved in the mechanism underlying ovarian hormone
      change and binge eating.
    

Eligibility criteria:

        Inclusion Criteria

        Participants will be women aged 18-42 with a current DSM-5 bulimia nervosa (BN) diagnosis
        who meet the below criteria. Only participants capable of giving informed consent and
        understanding the risks associated with the study will be enrolled.

          -  A regular menstrual cycle for at least three months

          -  < 35 BMI > 18.5

          -  Free of medication or medical condition that impacts ovarian hormones or is
             contraindicated for use with study interventions (including birth control pills)

          -  Speaks English

        Exclusion Criteria

        Patients will not be permitted to enter this protocol if they have any of the following:

          -  peanut allergy

          -  bipolar or psychotic disorder;

          -  current substance use disorder or frequent binge drinking behavior;

          -  frequent diuretic or laxative use, ipecac use;

          -  currently smoking > 10 cigarettes daily;

          -  history of a suicide attempt or current suicidal ideation;

          -  endometriosis;

          -  abnormal genital/vaginal bleeding;

          -  undiagnosed enlargement of the ovaries;

          -  liver disease;

          -  breast cancer;

          -  personal history of blood clots (a history of blood clots in the legs or lungs; DVT);
             pregnancy related blood clots

          -  history of seizures or epilepsy;

          -  porphyria;

          -  diabetes mellitus;

          -  malignant melanoma;

          -  gallbladder or pancreatic disease;

          -  heart or kidney disease;

          -  cerebrovascular disease (stroke);

          -  history of osteoporosis or osteopenia;

          -  recurrent migraine with aura;

          -  first degree relative (immediate family) with premenopausal breast cancer or breast
             cancer presenting in both breasts or any woman who has multiple family members
             (greater than three relatives) with postmenopausal breast cancer will also be excluded
             from participating in this protocol;

          -  Refusal to use non-hormonal contraception throughout study;

          -  Pregnant women will be excluded from participation (patients will be warned not to
             become pregnant during the study and will be advised to employ barrier contraceptive
             methods), and women who become pregnant (although unlikely because of the hormone
             manipulation) will be withdrawn;

          -  Any condition or symptoms considered by the study team to detrimentally impact subject
             safety.