A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder
ConditionBinge-eating Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- TNX-1900 (Tonix Pharmaceuticals)
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov