RECRUITING

A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder

Conditions

Binge-eating Disorder Binge Oxytocin Over-eating Impulse Control

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \[reduction in bingeing frequency\], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention.

Official Title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder

Quick Facts

Study Start:2023-03-07

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05664516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Males and females, 18-70 years old * BMI greater than or equal to 18.5 * BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) OR Other Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of low frequency and/or limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) through excessive exercise and/or fasting to avoid gaining weight after episodes of binge eating. For individuals with OSFED-BED, the frequency of subjective and objective binge eating episodes will meet the frequency (Criterion D) for BED.	* Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results * Medication changes that have not reached steady state concentration, measured by the equivalent of 5 half-lives of that medication * Use of medications for binge eating disorder or weight loss unless at a stable dose for at least 12 weeks * History of any of the following medical conditions: inflammatory bowel disease; epilepsy; untreated thyroid disease * History of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT * Hematocrit \>2% below normal * Hemoglobin A1c \>8% * Use of insulin * ALT or AST \>2.5 times upper limit of normal * Glomerular filtration rate \< 60 mL/min * Hyponatremia. Note that, in order to be randomized, subjects must have Na ≥ 135 mEq/L. * Pregnancy or breastfeeding * Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only) * History of psychosis or active suicidal ideation * Major depressive disorder likely to require initiation or change in active treatment * Borderline personality disorder as assessed by the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) * Current nicotine use, unless stable use for at least 12 weeks. * Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization * Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or subject safety

Inclusion Criteria

Exclusion Criteria

* Males and females, 18-70 years old
* BMI greater than or equal to 18.5
* BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) OR Other Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of low frequency and/or limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) through excessive exercise and/or fasting to avoid gaining weight after episodes of binge eating. For individuals with OSFED-BED, the frequency of subjective and objective binge eating episodes will meet the frequency (Criterion D) for BED.

* Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results
* Medication changes that have not reached steady state concentration, measured by the equivalent of 5 half-lives of that medication
* Use of medications for binge eating disorder or weight loss unless at a stable dose for at least 12 weeks
* History of any of the following medical conditions: inflammatory bowel disease; epilepsy; untreated thyroid disease
* History of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT
* Hematocrit \>2% below normal
* Hemoglobin A1c \>8%
* Use of insulin
* ALT or AST \>2.5 times upper limit of normal
* Glomerular filtration rate \< 60 mL/min
* Hyponatremia. Note that, in order to be randomized, subjects must have Na ≥ 135 mEq/L.
* Pregnancy or breastfeeding
* Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
* History of psychosis or active suicidal ideation
* Major depressive disorder likely to require initiation or change in active treatment
* Borderline personality disorder as assessed by the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD)
* Current nicotine use, unless stable use for at least 12 weeks.
* Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization
* Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or subject safety

Contacts and Locations

Study Contact

Lauren Shabazian, NP

CONTACT

617-726-0047

lshabazian@mgh.harvard.edu

Jordan Hillard

CONTACT

617-726-0047

jhillard1@mgh.harvard.edu

Principal Investigator

Elizabeth A Lawson, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Neuroendocrine Unit Research Center

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Elizabeth A Lawson, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-07

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-03-07

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Binge
Binge-eating disorder
Oxytocin
Over-eating
Impulse Control

Additional Relevant MeSH Terms

Binge-eating Disorder