High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin for tinnitus.

It had two arms (groups): one (experimental) and Nasal spray (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

This is a pilot, proof of concept, placebo-controlled, parallel study.

Who Took Part

Enrollment: 33 actual participants took part.

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

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

Examples of who could join: Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration. Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of \> 16. Subjects must have tinnitus loudness rating of \>4/10.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: subjects who are being treated for tinnitus \< 6 months due to the acute nature of their condition; subjects who have a slight handicap according to the tinnitus handicap inventory severity scale; those with tinnitus of a muscular or vascular etiology.

How the Study Was Run

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

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

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the tinnitus 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 and investigator.

It started in 2020-01-15 with completion listed for 2022-05-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness (time frame: Baseline, Week 9).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 33 people with tinnitus.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, Tinnitus research.