Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders including autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity. The primary objective of this study is to identify any differences between single dose 8 or 24 international units (IU) oxytocin delivered intranasally with the optimised OptiNose device and 1 IU oxytocin administered as slow intravenous infusion in healthy volunteers. This will be measured in terms of brain activity as measured with functional magnetic resonance imaging (fMRI), performance on cognitive tests, and physiological markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
19
Norwegian Centre for Mental Disorders Research (NORMENT), KG Jebsen Centre for Psychosis Research - TOP Study
Oslo, Norway
Aim 1a: Brain activity
Scanning procedures for functional magnetic resonance imaging (fMRI) will include a functional scan during a social cognition task and structural connectivity during rest
Time frame: 30 minutes after oxytocin/placebo administration
Aim 1b: Performance on a social cognition test
Participants will complete a task evaluating emotional expressions (either happy expressions, fear expressions or neutral expressions). These stimuli are identical to those published previously by Leknes et al., (2012).
Time frame: 45 mins after oxytocin/placebo administration
Aim 1c: Heart rate variability
Electrocardiogram data will be collected to assess heart rate variability, a measure of cardiac autonomic function.
Time frame: 20 minutes after oxytocin placebo administration
Aim 1d: Eyetracking
An eyetracking device will measure eyegaze and pupillometry.
Time frame: 20 minutes after oxytocin placebo administration
Pharmacokinetic (PK) profile of oxytocin
Blood will be collected to assess levels of oxytocin present in peripheral blood to measure PK profile of 8 and 24 international units (IU) oxytocin delivered with OptiNose device and of 1 IU oxytocin after slow intravenous (IV) infusion.
Time frame: 5 minutes prior to oxytocin/placebo administration
Plasma concentration of cortisol
Blood will be drawn at various intervals for the pharmacokinetic analysis of plasma cortisol.
Time frame: 20 minutes before fMRI procedure
Oxytocin levels in saliva
Saliva will be collected for pharmacokinetic analysis of oxytocin and cortisol in saliva.
Time frame: 20 prior to fMRI procedure
Cortisol levels in saliva
Saliva will be collected for pharmacokinetic analysis of oxytocin and cortisol in saliva.
Time frame: 20 minutes prior to fMRI procedure
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