Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers

What Was Tested

The trial (phase 4) is built around Oxytocin.

This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.

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

The registry classes the interventions as drug.

More on the Plan

Impaired social functioning is an important feature of substance use disorders.

Social deficits are a risk factor for developing substance use disorders as well as a consequence of substance abuse.

The specific aims are: 1.

To examine the effects of intranasal oxytocin administration on social cognition in moderate to heavy social alcohol drinkers. 2.

Who Took Part

Enrollment: 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Subject is a volunteer between 18 and 50 years of age. If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[IUD\], hormonal birth control, or barrier method). Subject is able to read and speak English. Subject is able and willing to provide written informed consent. Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: positive urine drug screen (except marijuana); marijuana use more than 3 times/week; has a neurological dysfunction or psychiatric disorder (confirm with study physician).

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant and investigator.

It started in 2013-05 with completion listed for 2014-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study (time frame: Measured just prior to and after each of the water and alcohol cues at visits 2 and 3).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 32 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.