Alcohol and Cigarette Craving During Oxytocin Treatment

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

Non treatment-seeking smokers with an AUD will be recruited to participate in a between-subjects, placebo-controlled, randomized pilot functional magnetic resonance imaging (fMRI) study.

It had two arms (groups): Oxytocin nasal spray (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 19 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Male or female. 18 to 55 years of age. Smoke at least ≥5 cigarettes/day for at least a year, verified with breath carbon monoxide level \> 5 ppm. In good health as confirmed by medical history, physical examination and lab tests. Willing to take the medication and adhere to the study procedures.

The full record lists 11 inclusion and 18 exclusion criteria; among the exclusions: positive urine test for pregnancy; women who are breast-feeding; body mass index \> 40.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2020-11-09 with completion listed for 2024-04-02.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Cigarette craving (time frame: 1 day). Brain activity (time frame: 1 day).

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.