Binge Eating & Birth Control

NCT04278755 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 19-3149
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

  Pre-intervention (week 1) to intervention endpoint (week 12)

• 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.

  Pre-intervention (week 1) to intervention endpoint (week 12)

• 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.

  Pre-intervention (week 1) to intervention endpoint (week 12)

• 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.

  Pre-intervention (week 1) to intervention endpoint (week 12)

• 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.

  Pre-intervention (week 1) to intervention endpoint (week 12)

• 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.

  Pre-intervention (week 1) to intervention endpoint (week 12)

Secondary Outcomes (2)

• Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score

  Pre-intervention (week 1) to intervention endpoint (week 12)

• Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score

  Pre-intervention (week 1) to intervention endpoint (week 12)

Study Arms (1)

Continuous OC

EXPERIMENTAL

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

Drug: Drospirenone-Ethinyl Estradiol Oral Tablet

Interventions

Drospirenone-Ethinyl Estradiol Oral Tablet DRUG

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

Also known as: Yasmin

Continuous OC

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Men will not be included in this study given the stated purpose to study ovarian hormones.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (83)

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MeSH Terms

Conditions

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

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated early due to the inability to recruit eligible participants therefore only a very small number of participants have available data.

Results Point of Contact

• Title: Jessica Baker, PhD
• Organization: University of North Carolina at Chapel Hill

jhbaker@med.unc.edu

984-974-3929

Study Officials

• Jessica Baker, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: September 24, 2020
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: July 26, 2022
• Results First Posted: July 26, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Deidentified individual data that supports the results will be shared beginning 18 to 24 months following publication upon reasonable request.
• Access Criteria: Approval from an IRB, IEC, or REB, as applicable and execution of a data use/sharing agreement with UNC.

Locations

US (1)