The Effects of Oxytocin on Startle Hyperreactivity in Patients With AUD and PTSD

What Was Tested

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

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

Subjects will receive intranasal saline spray.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 88 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Ages 18 to 75 (inclusive). Current DSM-V diagnosis of PTSD. Current (past month) DSM-V diagnosis of a moderate to severe Alcohol Use Disorder.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: current or lifetime psychotic disorders, such as schizophrenia or bipolar disorder; dementia or other neuropsychiatric disorders involving cognitive deficits or active symptoms impairing their ability to complete study tasks; use of disulfiram, naltrexone, or acamprosate for alcohol use disorder in the past week.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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 and investigator.

It started in 2016-02 with completion listed for 2018-02-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Social Perception measured by score on the Reading the Eyes in the Mind Test. Alcohol Approach Bias measured by score on the Approach Avoidance Task. Startle Hyperactivity measured by heart rate change score in response to startle stimuli.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 88 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.