Intranasal Oxytocin for Easing Benzodiazepine Withdrawal Symptoms in Adults A Controlled Pilot Study

What this Trial Is About

This research aims to evaluate whether intranasal oxytocin can reduce withdrawal symptoms in adults tapering off benzodiazepines over 21 days. The study focuses on whether oxytocin can ease withdrawal challenges such as anxiety, sleep difficulties, restlessness, and cravings. It is a phase 2 randomized, placebo-controlled trial comparing oxytocin with a saline placebo to understand its safety and effectiveness. Participants will be randomly assigned to either receive oxytocin nasal spray or a placebo spray. The oxytocin group will receive 48 international units daily, given as 4 puffs 2 in each nostril three times a day for 21 days. Both groups will self-administer their assigned nasal spray throughout an inpatient benzodiazepine tapering period. The placebo contains saline and is administered identically to the oxytocin. During the study, participants will complete daily online questionnaires to record their withdrawal symptoms and side effects. Researchers will monitor withdrawal symptoms using the CIWA-B scale, anxiety with the Hamilton Anxiety Rating Scale, and sleep quality via the Pittsburgh Sleep Quality Index and actigraphy. Weekly urine and blood samples will be collected. Participants will also be assessed at the end of treatment and at follow-up points four and twelve weeks later to observe lasting effects.

Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT