A Phase 2 Randomized, Double-Blind Study of Intranasal Oxytocin Compared to Placebo in Adults with Binge-Eating Disorder to Assess Treatment Effects

What this Trial Is About

Researchers are evaluating the effects of intranasal oxytocin compared to a placebo in adults diagnosed with binge-eating disorder or episodes of bingeing. The study aims to see if 8 weeks of oxytocin treatment can reduce the frequency of binge episodes and assess its safety and tolerability. Additionally, the study will explore how changes in appetite control, reward sensitivity, and impulse control after 4 weeks may predict treatment success by week 8. At least 60 eligible adults will be randomly assigned to receive either oxytocin nasal spray or a placebo nasal solution without oxytocin in a double-blind setup. Participants will use the assigned nasal spray for 8 weeks. The study includes an 8-week treatment period followed by an 8-week post-treatment observation phase. Evaluations occur at baseline, week 2, week 4, week 8, and week 16 to monitor progress and effects. Throughout the study, participants will undergo medical history reviews, physical exams, body measurements, lab tests, EKGs, and assessments of eating habits. Researchers will measure binge frequency as the primary outcome at 8 weeks, along with reward sensitivity and impulse control as secondary outcomes. Follow-up visits at week 16 will help assess any lasting effects after treatment ends, ensuring thorough safety monitoring and data collection over the total study period.

A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder