Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Benzodiazepine Dependence
In brief
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.
Key facts
- Study ID
- NCT06757517
- Run by
- St. Olavs Hospital
- People needed
- 60
- Starts
- 2022-03-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-01-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged 18 - 65 years, taking benzodiazepines at a daily dose of 20-80 mg diazepam-equivalent, and requiring inpatient benzodiazepine withdrawal. Included patients must consent to participate in the study.
You may not qualify if…
- Female patients will be excluded if they are pregnant or are planning to become so, or if they are breast-feeding. Individuals incapable of completing questionnaires or giving informed consent will be excluded. Patients with concurrent acute medical or psychiatric illness requiring acute care hospitalization, misuse or dependency of alcohol or pregabalin/gabapentin will be excluded.
Where it is running
- Blue Cross, Clinic Lade — Trondheim, Trøndelag, Norway (enrolling)
Full record on ClinicalTrials.gov
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