Mindfulness Training Plus Oxytocin Effects on Smoking Behavior

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.

It had three arms (groups): Mindfulness and intranasal oxytocin (experimental), Mindfulness and placebo (active comparator) and Sham mindfulness and placebo (sham comparator).

Given oxytocin through intranasal administration and self-directed mindfulness training.

Given sterile saline through intranasal adminstration and self-directed mindfulness training.

Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.

The registry classes the interventions as behavioral and drug.

More on the Plan

Mindfulness training allows individuals to be present with their own emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the form of daily audio recordings.

Oxytocin is a naturally occurring hormone in the brain and throughout the body.

It is also an FDA-approved drug to help induce labor in pregnant women.

In this study, the use oxytocin is experimental and is in the form of a nasal spray.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Smoke at least 10 cigarettes per day for the past year.

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: current dsm-5 substance use disorder; women who are pregnant or nursing; current use of psychiatric medication for anxiety or mood disorders.

How the Study Was Run

It was run as a randomized, factorial and double-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

Those kept unaware of assignments: participant and investigator.

It started in 2018-10-10 with completion listed for 2023-12-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Smoking Lapse Analogue Task (delay score) (time frame: 2 hours after nasal spray administration). Trier Social Stress Test (time frame: 1 hour after nasal spray administration).

It also tracked 3 secondary outcomes, for example Systolic blood pressure, Diastolic blood pressure and Heart rate.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 20 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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