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Oxytocin 2023-03-07 ClinicalTrials

Intranasal Oxytocin Trial Investigates Efficacy in Adults with Binge-Eating Disorder

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

Background

Binge-eating disorder (BED) is the most prevalent eating disorder, affecting millions globally, characterized by recurrent episodes of consuming unusually large amounts of food, often accompanied by a distressing sense of lack of control. Unlike bulimia nervosa, BED episodes are not followed by compensatory behaviors. Current pharmacological treatments, such as certain antidepressants or lisdexamfetamine, have limited efficacy or significant side effects, leaving a substantial unmet need for effective and well-tolerated therapies. Oxytocin, a hypothalamic neuropeptide, plays a crucial role in social cognition, stress modulation, and importantly, in regulating feeding behavior, reward processing, and impulse control. Its ability to modulate neural circuits involved in these processes makes it a compelling candidate for investigating its therapeutic potential in BED, targeting the core behavioral and neurobiological dysregulations.

Study Design

This is a double-blind, randomized, placebo-controlled clinical trial designed to evaluate the therapeutic effects of intranasal oxytocin in adults diagnosed with binge-eating disorder or experiencing recurrent binge-eating episodes. Participants will receive either intranasal oxytocin or a matching placebo daily for a duration of 8 weeks. The primary outcome measure is the reduction in bingeing frequency, assessed using validated self-report questionnaires and clinical interviews. Secondary objectives include assessing changes in underlying mediators such as homeostatic appetite, reward sensitivity, and impulse control, which will be evaluated at 4 weeks and 8 weeks into the intervention using specific behavioral tasks and psychometric scales. The study also aims to rigorously evaluate the safety and tolerability profile of the 8-week intranasal oxytocin regimen.

Why It Matters

If intranasal oxytocin demonstrates efficacy and a favorable safety profile, it could represent a significant advancement in the treatment landscape for binge-eating disorder, a condition with high prevalence and often challenging management. The simplicity of an intranasal administration protocol for 8 weeks suggests a potentially accessible and patient-friendly therapeutic option, which could be integrated into existing treatment paradigms or offered as a standalone intervention. Furthermore, by exploring the impact on specific underlying mediators like reward sensitivity and impulse control, this research has the potential to deepen our understanding of BED's neurobiology. This could pave the way for more targeted interventions, refine patient selection for oxytocin therapy, and inform future combination strategies, ultimately improving outcomes for individuals struggling with this debilitating disorder.


Source: clinicaltrials:NCT05664516 · Ingested 2026-07-01 · Digest: gemini-2.5-flash