Intranasal Oxytocin for the Treatment of Alcohol Use Disorder

What Was Tested

This registered phase 2 trial tested Oxytocin.

A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.

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

The registry classes the interventions as drug.

Who Took Part

100 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Be at least 21 years of age. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent). Double barrier (diaphragm/spermicidal or condom/spermicidal),. Intrauterine contraceptive system,. Medroxyprogesterone acetate contraceptive injection,.

The full record lists 32 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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

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

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 2022-06-29 with completion listed for 2023-10-13.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weekly Percentage of Heavy Drinking Days (time frame: Weeks 3-12).

It also tracked 17 secondary outcomes, for example Percentage of Subjects With no Heavy Drinking Days, Percentage of Days Abstinent Per Week, Weekly Mean Number of Drinks Per Week, Weekly Mean Drinks Per Drinking Day, Cigarettes Smoked Per Week Among Smokers and Abstinence From Cigarette Smoking Among Smokers.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 100 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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