Cocaine Opioid Oxytocin Option - Limited

What Was Tested

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

This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.

It had two arms (groups): Patients 1 (active comparator) and Patients 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: At least one routine urine toxicology screen positive for cocaine in the past month.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: positive urine pregnancy test; use of illicit drugs in the past month (with the exception of cocaine or cannabis); currently meets diagnostic and statistical manual-5 (dsm-v) criteria for severe major depressive disorder with suicidal thoughts or actions.

How the Study Was Run

The set-up was randomized, single-group and quadruple-blind.

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

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2014-07 with completion listed for 2014-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Number of patients with non-serious and serious adverse events (time frame: 3 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 30 people.

Its size is small, so on its own it can only give an early look.

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.