Binge-eating DisorderPhase 2STROBENCT05664516
A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
A Phase 2 study testing TNX-1900 (Tonix Pharmaceuticals) in people with Binge-eating Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Binge-eating Disorder
- What is being tested?
- TNX-1900 (Tonix Pharmaceuticals)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 or untreated thyroid disease
- Uncontrolled epilepsy (as defined by a seizure within the last 12 months)
- Clinically relevant ventricular arrhythmias, coronary heart disease, known long QTc, and hypertrophic cardiomyopathy
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Neuroendocrine Unit Research Center
Boston, Massachusetts, 02114
Lauren Shabazian, MSN, 627-726-0047, lshabazian@mgh.harvard.edu
Frances Ross, 627-726-0047, fross2@mgh.harvard.edu
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder
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.
Read the 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, week 8, and week 16 (8 weeks post-treatment).
- Conditions
- Binge-eating Disorder
- Being tested
- TNX-1900 (Tonix Pharmaceuticals), Placebo
- Keywords
- Binge, Binge-eating disorder, Oxytocin, Over-eating, Impulse Control
- Medical subject headings
- Binge-Eating Disorder, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-1900 (Tonix Pharmaceuticals)Drug
oxytocin nasal spray
PlaceboDrug
Nasal solution without oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Solution without oxytocin Receives: Drug: Placebo |
| TNX-1900 | Experimental | Solution with oxytocin Receives: Drug: TNX-1900 (Tonix Pharmaceuticals) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Frequency
Change in binge frequency as assessed by the Eating Disorder Examination clinical interview
Measured: 8 weeks
Secondary outcomes (2)
Reward sensitivity
Predictive value of 4-week change in reward sensitivity per the Temporal Experience of Pleasure Scale (TEPS) Anticipatory Experience of Pleasure subscale score for 8-week change in binge episodes. Higher scores=greater anticipatory pleasuure/less anhedonia. Minimum/Maximum: 10-60
Measured: 8 weeks
Impulse control
Predictive value of 4 week change in impulse control per Stop-Signal Reaction time in a Stop-Signal Task for 8 week change in binge frequency
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start7 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-eating DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Austen Lawson, Massachusetts General Hospital
- Investigators
- Elizabeth A Lawson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664516
- Sponsor's protocol ID
- 2022P002727
- Acronym
- STROBE
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder
- ClinicalTrials.gov ID
- NCT05664516
- Acronym / sponsor ID
- STROBE / 2022P002727
- Conditions
- Binge-eating Disorder
- Keywords
- Binge, Binge-eating disorder, Oxytocin, Over-eating, Impulse Control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, week 8, and week 16 (8 weeks post-treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: PlaceboSolution without oxytocin |
| TNX-1900 | Experimental | Drug: TNX-1900 (Tonix Pharmaceuticals)Solution with oxytocin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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 or untreated thyroid disease
- Uncontrolled epilepsy (as defined by a seizure within the last 12 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNX-1900 (Tonix Pharmaceuticals)oxytocin nasal spray | Drug | TNX-1900 |
| PlaceboNasal solution without oxytocin | Drug | Placebo Arm |
Primary outcome
Binge Frequency
Time frame: 8 weeks
Change in binge frequency as assessed by the Eating Disorder Examination clinical interview
2 secondary outcomes
Reward sensitivity
Time frame: 8 weeks
Impulse control
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth A Lawson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNX-1900 (Tonix Pharmaceuticals) in people with Binge-eating Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Shabazian, NP (617-726-0047, lshabazian@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Frequency (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.