Oxytocin Treatment of Alcohol Withdrawal

What Was Tested

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

Also, determine rates of subject recruitment and retention in the inpatient setting.

Participants: 80 alcohol dependent patients, 18-65 years of age, admitted for medical detoxification.

It had two arms (groups): intranasal spray without oxytocin (placebo comparator) and intranasal oxytocin spray (experimental).

Twice daily intranasal spray without oxytocin.

Twice daily intranasal oxytocin spray.

The registry classes the interventions as drug and other.

More on the Plan

Treatment group assignment will be random within each sex.

Each treatment group will be composed of up to 40 subjects.

Hamer, the study statistician, will construct a randomization plan to randomize 80 subjects to 2 groups of 40 subjects each with a blocksize of 4.

This will be a permuted blocksize as this is a blind study.

Who Took Part

Enrollment: 14 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: Daily consumption of 6 or more alcohol drinks/day for at least 2 weeks prior to admission. Only one of the following two conditions must be met:.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: low literacy as indicated by an inability to read and understand the consent form; dependence on substances other than alcohol, nicotine, caffeine or cannabis; history of alcohol withdrawal-related seizures, delirium tremens or hallucinations.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2010-07 with completion listed for 2011-03.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example CIWA-Ar Scores.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 14 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.