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New treatment option for Binge-eating Disorder
Official title A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
ClinicalTrials.gov ID: NCT05664516
What this study is testing
What is TNX-1900 (Tonix Pharmaceuticals)?
TNX-1900 (Tonix Pharmaceuticals) is an investigational medicine, being studied as a potential treatment for binge-eating disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
You likely can't join if
- Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study...
- 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
See the full eligibility 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...
- 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
- 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 assigned by chance, people 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.