Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT
ConditionBenzodiazepine Dependence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Olavs Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Oxytocin nasal spray
- Saline (NaCl 0,9 %) (placebo)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
St. Olavs Hospital
Lead sponsor
Norwegian University of Science and Technology
Collaborator
Lade Behandlingssenter, Blå Kors
Collaborator
Source ClinicalTrials.gov