Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated January 3, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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 question 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 nasalspray, thrice daily for 21 days during inpatient benzodiazepine tapering. Fill out an online questionnaire every day and keep a record of their symptoms.
Trial Details
NCT Number NCT06757517
Lead Sponsor St. Olavs Hospital
Collaborators: Norwegian University of Science and Technology, Lade Behandlingssenter, Blå Kors
Conditions Benzodiazepine Dependence
Enrollment 60 participants
Start Date 2022-03-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-03