The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults

What Was Tested

The trial (early phase 1) is built around Oxytocin.

In a 6-session laboratory study, the researchers will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, and decision-making.

It had six arms (groups): one (active comparator), one (active comparator), one (active comparator), one (active comparator) and one (active comparator).

Combined effects of oxycodone and oxytocin.

Combined effects of oxycodone and oxytocin.

The registry classes the interventions as drug and other.

More on the Plan

Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study.

Prescreening will assure drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.

Who Took Part

The registry lists 45 planned participants were the target.

It was open to people of any sex aged from 45 years up to 85 years.

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

Examples of who could join: Individuals fluent in English will participate. Must report some experience with opioids (e.g., oxycodone, defined as use at least once in the subject's lifetime). Are not currently experiencing chronic pain (pain on most days during the past 3 months). Have a systolic blood pressure of \<=140 and diastolic blood pressure of \<= 90, and a heart rate \<= 90 beats per minute. Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: women who are pregnant or nursing.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2023-09-12 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 45 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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