Actively Recruiting
Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot Randomized Parallel Group Placebo-Controlled Trial
Led by St. Olavs Hospital · Updated on 2025-01-03
60
Participants Needed
1
Research Sites
N/A
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
This research aims to evaluate whether intranasal oxytocin can reduce withdrawal symptoms in adults tapering off benzodiazepines over 21 days. The study focuses on whether oxytocin can ease withdrawal challenges such as anxiety, sleep difficulties, restlessness, and cravings. It is a phase 2 randomized, placebo-controlled trial comparing oxytocin with a saline placebo to understand its safety and effectiveness. Participants will be randomly assigned to either receive oxytocin nasal spray or a placebo spray. The oxytocin group will receive 48 international units daily, given as 4 puffs (2 in each nostril) three times a day for 21 days. Both groups will self-administer their assigned nasal spray throughout an inpatient benzodiazepine tapering period. The placebo contains saline and is administered identically to the oxytocin. During the study, participants will complete daily online questionnaires to record their withdrawal symptoms and side effects. Researchers will monitor withdrawal symptoms using the CIWA-B scale, anxiety with the Hamilton Anxiety Rating Scale, and sleep quality via the Pittsburgh Sleep Quality Index and actigraphy. Weekly urine and blood samples will be collected. Participants will also be assessed at the end of treatment and at follow-up points four and twelve weeks later to observe lasting effects.
CONDITIONS
Brief 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
- Require inpatient benzodiazepine withdrawal
- Provide informed consent to participate in the study
You will not qualify if you...
- Female patients who are pregnant, planning pregnancy, or breastfeeding
- Unable to complete questionnaires or give informed consent
- Have acute medical or psychiatric illness needing hospitalization
- Misuse or dependency of alcohol, pregabalin, or gabapentin
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants self-administer intranasal oxytocin or placebo three times daily for three weeks while completing daily symptom questionnaires and providing weekly urine and blood samples.
Weekly visits for sample collection and daily symptom monitoring
Duration - Up to 12 weeks post-treatment
Participants are assessed at the end of treatment and again at four and twelve weeks post-treatment to evaluate the persistence of effects.
3 visits (in-person) after treatment completion
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
O
Olav Spigset MD, Professor of Clinical Pharmacology
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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