Oxytocin Treatment for Alcohol Use Disorders

What Was Tested

This registered phase 2 trial tested Oxytocin.

The lower drinking criteria will be minimum of 14 drinks/week (women) or 21 drinks/week (men) with an average of at least two heavy drinking days (≥5 standard drinks for men and ≥4 standard drinks for women) each week in the 4-week period prior to screening.

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

The registry classes the interventions as drug.

More on the Plan

Treatment assignments will be counterbalance within gender and within the moderate and severe AUD groups.

Baseline measures of drinking, craving and anxiety will be covariates in statistical comparisons between the treatment groups of outcomes over the course of the treatment trial and the follow-up period.

Respondents to advertisements will have a preliminary telephone screening conducted by the study coordinator.

Individuals who appear eligible, as determined by the investigative team, will be scheduled for more comprehensive in-person screening.

Who Took Part

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Ability to understand and sign written informed consent. Must have a 0.0 gms/dL breathalyzer reading on the day of screening and \< 0.4 gms/dL on the day of randomization. Must have a stable residence and be able to identify an individual who could contact participant if needed.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: substance use disorder other than nicotine use disorder or mild cannabis use disorder. occasional use of cocaine is acceptable; prior history of adverse reaction to oxytocin; serum sodium concentration \< 134 meq/l.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

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, care provider and investigator.

It started in 2019-10 with completion listed for 2022-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean heavy drinking days (time frame: 24 weeks). Mean drinks per drinking day (time frame: 24 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, 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.