Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Healthy Adults

What Was Tested

This registered phase 1 trial tested Oxytocin.

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 19 actual participants took part.

It was open to men only aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy, male subjects aged 18 to 35 years inclusive. Subjects must be in good general health, as determined by the investigator. Heart rate: 40 to 90 beats per minute. Systolic blood pressure (BP): 90 to 140 mmHg. Diastolic BP: 50 to 90 mmHg.

The full record lists 11 inclusion and 18 exclusion criteria; among the exclusions: participants with evidence of previous nasal disease, surgery, and dependence on inhaled drugs; systemic illness requiring treatment within 2 weeks prior to study day 1; full scale intelligence quotient (iq) \< 75 (due to the prerequisite ability to complete self report measures).

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2013-10 with completion listed for 2014-02.

It ran at 1 site in Norway.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Aim 1a: Brain activity (time frame: 30 minutes after oxytocin/placebo administration). Aim 1b: Performance on a social cognition test (time frame: 45 mins after oxytocin/placebo administration). Aim 1c: Heart rate variability (time frame: 20 minutes after oxytocin placebo administration).

It also tracked 4 secondary outcomes, for example Plasma concentration of cortisol, Oxytocin levels in saliva and Cortisol levels in saliva.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 19 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.