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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
oxytocin nasal spray
Nasal solution without oxytocin
Neuroendocrine Unit Research Center
Boston, Massachusetts, United States
RECRUITINGBinge Frequency
Change in binge frequency as assessed by the Eating Disorder Examination clinical interview
Time frame: 8 weeks
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
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
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