NCT05664516

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
7mo left

Started Mar 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

December 16, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 18, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

December 16, 2022

Last Update Submit

November 16, 2025

Conditions

Binge-eating Disorder

Keywords

BingeBinge-eating disorderOxytocinOver-eatingImpulse Control

Outcome Measures

Primary Outcomes (1)

  • Binge Frequency

    Change in binge frequency as assessed by the Eating Disorder Examination clinical interview

    8 weeks

Secondary Outcomes (2)

  • Reward sensitivity

    8 weeks

  • Impulse control

    8 weeks

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Solution without oxytocin

Drug: Placebo

TNX-1900

EXPERIMENTAL

Solution with oxytocin

Drug: TNX-1900 (Tonix Pharmaceuticals)

Interventions

TNX-1900 (Tonix Pharmaceuticals)DRUG

oxytocin nasal spray

TNX-1900
PlaceboDRUG

Nasal solution without oxytocin

Placebo Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuroendocrine Unit Research Center

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Binge-Eating DisorderHyperphagia

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth A Lawson, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Shabazian, NP

CONTACT

617-726-0047lshabazian@mgh.harvard.edu

Jordan Hillard

CONTACT

617-726-0047jhillard1@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Study staff and patients are blinded. The pharmacist is unblinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Interdisciplinary Oxytocin Research Program

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 23, 2022

Study Start

March 7, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 18, 2025

Record last verified: 2025-06

Locations

US(1)