Effects of Intranasal Oxytocin on Cigarette Smoking

What Was Tested

This registered phase 4 trial tested Oxytocin.

Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural processes that encode, interpret, and respond to socially and emotionally relevant stimuli) have been implicated in tobacco smoking and relapse, however this potential target for medication development has not been systematically examined.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 83 actual participants took part.

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

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

Examples of who could join: Smoke \>= 10 cig/day for the past year.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: current dsm-5 substance use disorder, excluding nicotine dependence (to minimize alcohol or drug withdrawal symptoms during the study sessions); women who are pregnant or nursing; current use of psychiatric medication.

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

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 2016-07 with completion listed for 2019-07.

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: 2.5 hours after nasal spray administration). Brief Questionnaire of Smoking Urges (QSU) (time frame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray). Systolic Blood Pressure (mmHg) (time frame: 30 minutes before nasal spray, and 30, 60, and 90 minutes after nasal spray).

It also tracked 1 secondary outcome, for example Profile of Mood States (Anxious Scale).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 83 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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