Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II

What Was Tested

This registered phase 2 trial tested Oxytocin.

It had two arms (groups): Placebo (placebo comparator) and Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks.

With this study, the investigators will characterize oxytocin's effects on the neural processing of salient stimuli.

As such, it is important that the researchers obtain a better understanding of the neurobiological effects this drug may have on reward circuitry functioning.

To this end, in this study, the researchers will examine healthy control participants and participants diagnosed with Alcohol Use Disorder (AUD).

Who Took Part

Enrollment: 88 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: 18-45 years of age at the time of screening.

The full record lists 1 inclusion and 15 exclusion criteria; among the exclusions: psychiatric illness criteria:; controls: no current or past history of psychiatric illness, including substance use disorder (except nicotine); illicit drug use.

How the Study Was Run

Design: randomized, factorial and triple-blind.

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

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 and investigator.

It started in 2016-11 with completion listed for 2022-06.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: Control group (time frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)). Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group (time frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)). Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls (time frame: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 88 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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