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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TNX-1900 (Tonix Pharmaceuticals)

    Drug

    oxytocin nasal spray

  • Placebo

    Drug

    Nasal solution without oxytocin

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Placebo ArmPlacebo comparator 1 intervention
Group B: TNX-1900Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Binge Frequency

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

Time frame
8 weeks

Secondary outcomes

1

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

Time frame
8 weeks
2

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

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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