Oxytocin in Alcohol Use Disorder

What Was Tested

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

Background: Oxytocin is a naturally occurring substance in the body.

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

Intranasal oxytocin will be delivered on twice daily basis in this crossover trial.

Within Subject Design.

The registry classes the interventions as drug and other.

More on the Plan

Objective: There is compelling evidence to support that the neuropharmacology of oxytocin (OT) warrants further investigation as a potential therapeutic agent for addiction.

To that end, the link between OT and dopaminergic pathways, with respect to motivated behaviors such as drug and social reward, is important to establish as a mechanism.

Who Took Part

It was open to men only aged from 21 years up to 55 years.

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

Examples of who could join: Must meet DSM-5 criteria for AUD based on the SCID.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: current diagnosis of substance use disorder other than nicotine as determined by dsm-5; lifetime history of suicide attempts; BMI\>40 or if Investigators determine that subject s body shape precludes acquisition of an adequate MRI scan.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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 2016-03-08 with completion listed for 2019-02-22.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Stimulation Sedation; Cognitive Performance (time frame: Ongoing). BOLD response cognitive tasks and cues (time frame: Ongoing).

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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