Neurobiology of Bulimia Nervosa
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Jan 8, 2020
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
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 direct and mechanistic role of E2 and P4 on binge eating in women with bulimia...
Gender
FEMALE
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.
About University Of North Carolina, Chapel Hill
The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chapel Hill, North Carolina, United States
Patients applied
Trial Officials
Jessica Baker, PhD
Principal Investigator
University of North Carolina, Chapel Hill
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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