Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

What Was Tested

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

One of the adverse effects of abused drugs is their long-term negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation (McGregor et al., 2008).

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 73 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Male or female; any race or ethnicity; age 21-65 years. Female subjects will be required to complete the laboratory testing during the early to mid-follicular phase of their menstrual cycle (days 1-7 following the onset of menses). Veteran of the US military; any service branch. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments. Subjects must be able to comprehend English.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: must consent to random assignment to oxytocin or placebo; subjects on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks; subjects meeting dsm-5 criteria for another substance use disorder, except caffeine or nicotine, within the past 12 months.

How the Study Was Run

The set-up was randomized, factorial and double-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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-02 with completion listed for 2017-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Alcohol Craving (time frame: 2 hours).

It also tracked 1 secondary outcome, for example Stress Reactivity.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 73 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.