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

Binge-eating Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05664516
• Other study ID #: 2022P002727
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: Sarah Smith, NP
• Phone: 617-726-9394
• Email: SSMITH133[@]MGH.HARVARD.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders
• Obesity

Intervention

Drug:
• TNX-1900 (Tonix Pharmaceuticals)
oxytocin nasal spray
• Placebo
Nasal solution without oxytocin

Locations

Country	Name	City	State
United States	Neuroendocrine Unit Research Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight (kg)	Change from baseline in weight	8 weeks
Secondary	Binge Frequency	Change from baseline in binge frequency as assessed by the Eating Disorder Examination clinical interview	8 weeks