Study of Wellness Behaviors as a Function of Oxytocin vs Placebo

What Was Tested

This registered phase 1 trial tested Oxytocin.

It had four arms (groups): Oxytocin (experimental), Placebo (for oxytocin) (placebo comparator), Lovingkindness Meditation (experimental) and Mindfulness Meditation (placebo comparator).

Intranasal spray with all equivalent ingredients except oxytocin.

Lovingkindness guided meditation experienced in the laboratory and 6 additional LKM meditations taken home on the iPod.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 239 actual participants took part.

It was open to people of any sex aged from 35 years up to 64 years.

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

Examples of who could join: Between the ages of 35 and 64 years old. Fluent in written and spoken English. Willingness or interest in learning to meditate. Computer literate with access to internet (weekly).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: women who are pregnant or breastfeeding; individuals on antihypertensive medication; individuals who have or have had a regular meditation practice.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2013-09 with completion listed for 2014-09.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in positive emotions (as measured by the Modified Daily Emotions Scale) (time frame: Baseline and Weeks 1, 2, and 3). Change in nonconscious incentive salience (as measured by the Affect Misattribution Procedure) (time frame: Baseline and Weeks 1, 2, and 3). Changes in meditation time (time frame: Weeks 1, 2, and 3).

It also tracked 1 secondary outcome, for example Cardiac Vagal Tone.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 239 people.

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.