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

StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Trial completed Show 7 more changesShow less
    • Final enrollment: 66 participants (planned 60)
    • Primary completion date changed from estimate of Dec 31, 2025 to Nov 6, 2025
    • Study completion date changed from estimate of Dec 31, 2025 to Jan 29, 2026
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 31 words
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06757517
Lead Sponsor St. Olavs Hospital
Collaborators: Norwegian University of Science and Technology, Lade Behandlingssenter, Blå Kors
Conditions
(from sponsor)		 Benzodiazepine Dependence
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov