Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

This is a 2-arm placebo controlled study.

Subjects will complete a battery of self-report questionnaires and behavioral interviews.

Baseline assessments of subjective (craving, stress), physiologic (HR, BP), and neuroendocrine measures (salivary cortisol) will be collected.

These same assessments will be repeatedly collected throughout the testing portion of the study.

Who Took Part

63 actual participants took part.

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

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

Examples of who could join: Active Duty Service Members, any service branch; age 18-65 years. Meets clinician assessment for current PTSD OR anxiety disorder NOS OR scores on DASS \> 10 on Anxiety or \> 19 on Stress. Meets clinician assessment for alcohol use disorder (AUD) OR scores \>8 on AUDIT. If meet current or lifetime criteria for another substance disorder, must indicate that AUD is primary. Negative urine drug screen test and BAC =0.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: positive urine drug screen (except marijuana) or bac \> 0; untreated subjects currently symptomatic of psychotic or bipolar affective disorders; subjects with current suicidal or homicidal ideation and intent, who would present a serious suicide risk.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2017-04-20 with completion listed for 2019-07-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in Craving to Use Alcohol Rating (Visual Analog Scale) (time frame: Change from baseline to post-drug at 20 minutes).

It also tracked 1 secondary outcome, for example Change in Stress Rating (Visual Analog Scale).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 63 people.

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.