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Binge Eating & Birth Control

Primary Purpose

Bulimia Nervosa, Binge Eating, Eating Disorders

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drospirenone-Ethinyl Estradiol Oral Tablet
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bulimia Nervosa

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous OC

Arm Description

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

Outcomes

Primary Outcome Measures

Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency
Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention.
Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score
Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention.
Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k
The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention.

Secondary Outcome Measures

Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score
Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined as the average change in reward sensitivity from pre-intervention to intervention.
Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score
The Behavioral Inhibition/Behavioral Activation questionnaire will be used to assess behavioural inhibition (BI). The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater BI. Change is defined as the average change in BI from pre-intervention to intervention.

Full Information

First Posted
February 18, 2020
Last Updated
July 21, 2022
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04278755
Brief Title
Binge Eating & Birth Control
Official Title
A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Halted prematurely due to COVID-19-related enrollment challenges.
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
May 17, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Binge Eating, Eating Disorders, Binge-Eating Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous OC
Arm Type
Experimental
Arm Description
Continuous daily oral drospirenone + ethinyl estradiol for 84 days (i.e., 12-weeks).
Intervention Type
Drug
Intervention Name(s)
Drospirenone-Ethinyl Estradiol Oral Tablet
Other Intervention Name(s)
Yasmin
Intervention Description
3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
Primary Outcome Measure Information:
Title
Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency
Description
Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)
Title
Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score
Description
Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)
Title
Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Description
Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)
Title
Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Description
Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)
Title
Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
Description
Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)
Title
Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k
Description
The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)
Secondary Outcome Measure Information:
Title
Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score
Description
Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined as the average change in reward sensitivity from pre-intervention to intervention.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)
Title
Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score
Description
The Behavioral Inhibition/Behavioral Activation questionnaire will be used to assess behavioural inhibition (BI). The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater BI. Change is defined as the average change in BI from pre-intervention to intervention.
Time Frame
Pre-intervention (week 1) to intervention endpoint (week 12)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Men will not be included in this study given the stated purpose to study ovarian hormones.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Baker, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
IPD Sharing Time Frame
Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication upon reasonable request.
IPD Sharing Access Criteria
Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.
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