Oxytocin Treatment of Alcohol Dependence

What Was Tested

The trial (phase 2) is built around Oxytocin.

It had two arms (groups): Active (experimental) and Control (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Oxytocin is made naturally and is released in parts of the brain where it acts like a chemical signal from one cell to another.

Subjects will self-administer oxytocin or placebo in this study in an intranasal spray.

The placebo spray contains all of the ingredients of the oxytocin spray EXCEPT oxytocin.

Subjects' assignment to oxytocin or placebo treatment will be random (like a flip of a coin).

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Consumption of at least 35 standard drinks/week for men or 28 standard drinks/week for women for at least 4 consecutive weeks prior to enrollment into the study. Ability to get to appointments either through personal or public transportation.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: consumption during the week prior to enrollment or plans to consume during the 12-week trial of benzodiazepines, barbiturates, anticonvulsants or stimulants; women who are pregnant or breastfeeding.

How the Study Was Run

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

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 and investigator.

It started in 2015-07 with completion listed for 2016-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of Heavy Drinking Days (time frame: 12 weeks). Mean Weekly Drinks Per Drinking Day (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 22 people.

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

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.