Effects of Intranasal Oxytocin Nasal Spray in Treating Benzodiazepine Withdrawal Symptoms A Pilot Randomized Placebo-Controlled Trial in Adults Undergoing Benzodiazepine Tapering

What this Trial Is About

Researchers are evaluating whether oxytocin nasal spray can reduce withdrawal symptoms in adults undergoing benzodiazepine tapering. This pilot randomized controlled trial focuses on adults aged 18 to 65 who are dependent on benzodiazepines, aiming to see if oxytocin helps ease withdrawal symptoms such as anxiety, sleep difficulties, restlessness, and craving. The study also assesses the safety and tolerability of intranasal oxytocin during this process. Participants will be randomly assigned to receive either oxytocin nasal spray or a placebo saline nasal spray. The oxytocin is given as 4 insufflations (16 IU) three times daily, totaling 48 IU per day, for 21 days during inpatient benzodiazepine tapering. The study includes a screening phase, a treatment phase with daily dosing, and post-treatment follow-up assessments. During the study, participants will complete daily online questionnaires to record symptoms and side effects. Weekly urine and blood samples will be collected to monitor safety and treatment effects. Researchers will measure benzodiazepine withdrawal symptoms over 21 days as the primary outcome. Additional assessments include anxiety levels and sleep quality. Follow-up visits will occur four and twelve weeks after treatment to evaluate the lasting effects. Overall, participation lasts for several weeks covering treatment and follow-up periods.

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