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A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder (STROBE)

Primary Purpose

Binge-eating Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TNX-1900 (Tonix Pharmaceuticals)
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-eating Disorder focused on measuring Obesity, Weight Loss, Binge, Binge-eating disorder, Oxytocin, Overeating

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females, 18-45 years old BMI 30-50 kg/m2 BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) Exclusion Criteria: 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 within 4 weeks of baseline visit Use of prescription or over-the-counter drugs or dietary/herbal supplements for weight loss (e.g., lorcaserin, phentermine, topiramate, liraglutide). Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months History of any of the following medical conditions: inflammatory bowel disease; bariatric surgery (except for those participants with a history of laparoscopic adjustable gastric band surgery); 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% ALT or AST >2.5 times upper limit of normal Glomerular filtration rate < 60 mL/min Hyponatremia 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 suicidality as assessed by the SCID-5-RV Weight change >5 kg within 3 months prior to randomization Current smoking or tobacco use 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 patient safety

Sites / Locations

  • Neuroendocrine Unit Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Arm

TNX-1900

Arm Description

Solution without oxytocin

Solution with oxytocin

Outcomes

Primary Outcome Measures

weight (kg)
Change from baseline in weight

Secondary Outcome Measures

Binge Frequency
Change from baseline in binge frequency as assessed by the Eating Disorder Examination clinical interview

Full Information

First Posted
December 16, 2022
Last Updated
March 22, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05664516
Brief Title
A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder
Acronym
STROBE
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Obesity and Binge- Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluates the impact of intranasal oxytocin vs placebo in patients with obesity and binge eating disorder with obesity. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes [weight loss, 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
Detailed Description
Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, and week 8.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-eating Disorder
Keywords
Obesity, Weight Loss, Binge, Binge-eating disorder, Oxytocin, Overeating

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study staff and patients are blinded. The pharmacist is unblinded.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Solution without oxytocin
Arm Title
TNX-1900
Arm Type
Experimental
Arm Description
Solution with oxytocin
Intervention Type
Drug
Intervention Name(s)
TNX-1900 (Tonix Pharmaceuticals)
Intervention Description
oxytocin nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nasal solution without oxytocin
Primary Outcome Measure Information:
Title
weight (kg)
Description
Change from baseline in weight
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Binge Frequency
Description
Change from baseline in binge frequency as assessed by the Eating Disorder Examination clinical interview
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, 18-45 years old BMI 30-50 kg/m2 BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) Exclusion Criteria: 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 within 4 weeks of baseline visit Use of prescription or over-the-counter drugs or dietary/herbal supplements for weight loss (e.g., lorcaserin, phentermine, topiramate, liraglutide). Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months History of any of the following medical conditions: inflammatory bowel disease; bariatric surgery (except for those participants with a history of laparoscopic adjustable gastric band surgery); 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% ALT or AST >2.5 times upper limit of normal Glomerular filtration rate < 60 mL/min Hyponatremia 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 suicidality as assessed by the SCID-5-RV Weight change >5 kg within 3 months prior to randomization Current smoking or tobacco use 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 patient safety
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Smith, NP
Phone
617-726-9394
Email
SSMITH133@MGH.HARVARD.EDU
Facility Information:
Facility Name
Neuroendocrine Unit Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Smith, DNP, MSN

12. IPD Sharing Statement

Learn more about this trial

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

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