Oxytocin on Approach Bias and Craving

What Was Tested

The trial (phase 2) is built around Oxytocin.

This will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects.

This study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo.

In this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.

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

Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session.

Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 21 years up to 40 years.

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

Examples of who could join: Healthy volunteers who are 21-40 years of age. If female, 10 or more alcoholic drinks must be consumed weekly. If male, 14 or more alcoholic drinks must be consumed weekly. Meets DSM-V criteria for Alcohol Use Disorder (AUD). Score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT).

The full record lists 11 inclusion and 18 exclusion criteria; among the exclusions: positive urine drug screen (except marijuana); marijuana use more than 3 times/week; current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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, care provider, investigator and outcomes assessor.

It started in 2023-11-01 with completion listed for 2024-04-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Alcohol cue craving score (time frame: ~ 90 minutes post study drug administration). Image approach task (time frame: ~ 90 minutes post study drug administration).

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.