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Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT
Sponsor: St. Olavs Hospital
Summary
The goal of this clinical trial is to learn if oxytocin administered as a nasal spray will reduce withdrawal symptoms in adults during benzodiazepine tapering for 21 days. It will also learn about the safety of oxytocin. The main questions it aims to answer are: Does oxytocin reduce benzodiazepine withdrawal symptoms and make it easier to succeed tapering? Does oxytocin help reduce sleep difficulties and anxiety or restlessness during benzodiazepine tapering? Does oxytocin help reduce benzodiazepine craving? We will compare oxytocin nasal spray to a placebo nasal spray containing regular saline to see if oxytocin works accordingly. Participants will: Take oxytocin or a placebo nasal spray, three times daily for 21 days during inpatient benzodiazepine tapering. Fill out an online questionnaire every day and keep a record of their symptoms.
Official title: Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot Randomized Parallel Group Placebo-Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2022-03-01
Completion Date
2026-01-29
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
Oxytocin nasal spray
Syntocinon contains synthetic oxytocinfor intranasal use, 6.7 microg (4 IU) per dose. We are planning to use 4 insufflations (16 IU) three times daily (i.e. a total daily dose of 48 IU).
Saline (NaCl 0,9 %) (placebo)
Saline intranasal placebo comparator
Locations (1)
Blue Cross, Clinic Lade
Trondheim, Trøndelag, Norway