NCT06757517

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

Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot Randomized Parallell Group Placebo-Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background Benzodiazepine withdrawal can be challenging, often accompanied by severe anxiety, insomnia, and other withdrawal symptoms. Recent studies suggest that intranasal oxytocin (OT) may have anxiolytic properties and could potentially ease withdrawal symptoms. This pilot study aims to evaluate the efficacy and safety of intranasal OT in the treatment of benzodiazepine withdrawal. Objectives The primary objective is to evaluate if intranasal OT can reduce withdrawal symptoms in patients during benzodiazepine tapering. Secondary objectives include evaluating the safety and tolerability of intranasal OT and its impact on anxiety levels and sleep quality. Methods * Design: This is a randomized, parallel-group, placebo-controlled trial. * Participants: 60 adults (aged 18-65) who are undergoing benzodiazepine tapering. * Intervention: Participants will be randomly assigned to receive either intranasal OT (24 IU) or a placebo, administered twice daily for four weeks. * Assessments: Withdrawal symptoms will be measured using the Clinical Institute Withdrawal Assessment for Benzodiazepines (CIWA-B) scale. Anxiety levels will be assessed using the Hamilton Anxiety Rating Scale (HAM-A), and sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) and actigraphy recordings. Procedure 1. Screening: Eligible participants will undergo a screening process, including medical history, physical examination, and baseline assessments. 2. Randomization: Participants will be randomly assigned to the OT or placebo group. 3. Treatment Phase: Participants will self-administer the nasal spray thrice daily for three weeks. Participants will fill out daily questionnaires to monitor symptoms and side effects. Weekly urine- and blood samples will be collected. 4. Post-Treatment Follow-Up: Participants will be assessed at the end of the treatment period and again four and twelve weeks post-treatment to evaluate the persistence of effects. Expected Outcomes It is hypothesized that participants receiving intranasal OT will experience a significant reduction in withdrawal symptoms compared to the placebo group. Improvements in anxiety levels and sleep quality are also anticipated. Significance This study could provide preliminary evidence for the use of intranasal OT as a supportive treatment for benzodiazepine withdrawal, potentially improving patient outcomes and comfort during the tapering process.

Conditions

• Benzodiazepine Dependence

Interventions

Type	Name	Description
DRUG	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).
DRUG	Saline (NaCl 0,9 %) (placebo)	Saline intranasal placebo comparator

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-01-03
• Last updated: 2025-01-03

Locations

1 site across 1 country: Norway