Does Oxytocin Alter Tolerance to or Motivation for Alcohol

What Was Tested

The trial (phase 2) is built around Oxytocin.

If successful, this data could support a future project studying the effect of oxytocin on tolerance and alcohol seeking in humans.

It had two arms (groups): Clamp (experimental) and Progressive work for alcohol (experimental).

Repeated subjective and cognitive tests during a 4 hour session that includes a baseline period, an oxytocin or placebo delivery, absorption and testing period, and a 2 hour alcohol clamp. Oxytocin or placebo were delivered intranasally in two sessions, scheduled 3-4 weeks apart, double blind.

Progressive work alcohol exposure, 2 sessions (intranasal oxytocin or placebo), double blind. Note this Arm was not completed (see Overall Status for explanation of study termination).

The registry classes the interventions as drug.

More on the Plan

Specifically, experiments are planned to test the ability of oxytocin to reverse tolerance and alcohol seeking in humans by employing state-of-the-art computer-assisted intravenous alcohol administration.

Two separate experiments will be run.

In the first, tolerance will be assessed using sensitive tests of subjective response and cognitive function during an intravenous infusion that maintains a steady breath and therefore brain exposure to alcohol.

Who Took Part

6 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

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

Examples of who could join: Heavy alcohol drinkers. Able to understand/complete questionnaires and procedures in English. Have venous access sufficient to allow blood sampling.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: latex allergy; nasal condition that compromises delivery and/or absorption of intra-nasal oxytocin; pregnant or breast-feeding women.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 and investigator.

It started in 2022-01-16 with completion listed for 2023-12-21.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Subjective Effect of Alcohol - Craving. Subjective Effects of Alcohol - Intoxication. Stop Signal Response Task.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 6 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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