Oxytocin and Stress Response in Alcohol Use Disorder

What Was Tested

This registered phase 2 trial tested Oxytocin.

Individuals with alcohol use disorder (AUD) will complete one functional Magnetic Resonance Imaging (fMRI) scanning visit.

During the scan, they will perform the Montreal Imaging Stress Task (MIST), a social stress task.

It had two arms (groups): Oxytocin/alcohol use disorder (experimental) and Placebo/Alcohol use disorder (placebo comparator).

Participants will receive placebo (saline solution) prior to completing fMRI scanning procedures.

The registry classes the interventions as drug.

More on the Plan

Participants: Twenty-four individuals with AUD will be recruited through the Clinical Intake and Assessment (CIA) Core of the Alcohol Research Center (ARC).

Screening and basic assessments will be conducted by the CIA Core to determine eligibility and suitability for participation in this pilot project.

Each individual will sign an Institutional Review Board (IRB)-approved informed consent form.

Study Visit Assessments: The Drinking Motives Questionnaire Revised will be used to assess motivation for drinking across four subscales: (1) coping motives; (2) social motives; (3) conformity motives; and (4) enhancement motives.

Who Took Part

11 actual participants 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: Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. Meets the DSM 5 criteria for current alcohol use disorder. Reports drinking on average, at least 20 standard alcoholic drinks per week for at least the past three months. Currently not engaged in, and does not want treatment for, alcohol related problems. Lives within 50 miles of the study site.

The full record lists 9 inclusion and 16 exclusion criteria; among the exclusions: currently meets dsm 5 criteria for any other psychoactive substance use disorder; is determined; has current suicidal ideation or homicidal ideation.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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.

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, investigator and outcomes assessor.

It started in 2016-03 with completion listed for 2018-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Corticolimbic Functional Connectivity Based on fMRI Blood Oxygenation Level Dependent (BOLD) Response During the Stress Versus Neutral Conditions of the Montreal Imaging Stress Test Task Averaged Over the Second and Third Functional Runs (time frame: 60 minutes following medication (oxytocin or placebo)).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 11 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.