Actively Recruiting
Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT
Led by St. Olavs Hospital · Updated on 2025-01-03
60
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
N
Norwegian University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years
- Taking benzodiazepines at a daily dose of 20-80 mg diazepam-equivalent
- Requiring inpatient benzodiazepine withdrawal
- Able to provide consent to participate in the study
You will not qualify if you...
- Female patients who are pregnant, planning to become pregnant, or breastfeeding
- Individuals unable to complete questionnaires or give informed consent
- Patients with acute medical or psychiatric illness needing acute hospitalization
- Patients misusing or dependent on alcohol or pregabalin/gabapentin
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Blue Cross, Clinic Lade
Trondheim, Trøndelag, Norway, 7091
Actively Recruiting
Research Team
T
Tone Aurora Pleym, MD, PhD-candidate
CONTACT
O
Olav Spigset MD, Professor of Clinical Pharmacology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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