Intranasal Oxytocin Pilot RCT Aims to Reduce Benzodiazepine Withdrawal Symptoms

Managing benzodiazepine dependence and subsequent withdrawal is a significant clinical challenge, often leading to severe and protracted symptoms like anxiety, insomnia, and seizures. Current tapering protocols can be difficult to adhere to, with high rates of relapse due to the distress of withdrawal. There's a critical need for adjunctive therapies that can alleviate these symptoms without introducing new dependencies. Oxytocin, a neuropeptide known for its anxiolytic and prosocial effects, has shown promise in modulating stress responses and addiction-related behaviors, making it a compelling candidate for mitigating the neurobiological dysregulation associated with benzodiazepine withdrawal.

This is a pilot randomized, quadruple-blinded, placebo-controlled trial (NCT06757517) recruiting 60 adult participants undergoing benzodiazepine tapering. Participants are randomized to receive either intranasal oxytocin or saline placebo. The oxytocin arm receives 48 IU of synthetic oxytocin (Syntocinon, 6.7 microg/dose, 4 IU/dose) administered as 4 insufflations (16 IU) three times daily via nasal spray for 21 days. The placebo arm receives an identical regimen of 0.9% NaCl saline. The primary objective is to evaluate if intranasal OT can reduce withdrawal symptoms, with secondary objectives assessing safety, tolerability, anxiety levels, and sleep quality.

As this is a recruiting pilot randomized controlled trial (estimated completion December 2025), no results are available yet. The study aims to gather preliminary data on the efficacy and safety of intranasal oxytocin in mitigating benzodiazepine withdrawal symptoms.