High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

Phase 3TerminatedNCT04210310

NYU Langone Health33 enrolled

Overview

The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.

This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's Ear, Nose \& Throat (ENT) Department and will receive either high-dose intranasal oxytocin or a nasal spray containing Pcca Mucolox and distilled water, serving as the placebo. Long term treatment with high-dose oxytocin (45 IU four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tinnitus

Interventions

OxytocinDRUG

The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day

Placebo nasal sprayOTHER

A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray. * Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions. * Subjects who suffer from migraines. * Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.

Locations (1)

222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health

New York, New York, United States

Outcomes

Primary Outcomes

Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness

Participants use a VAS to rate the loudness of tinnitus on an 11-point Likert scale. Total scores range from 0 (minimum) to 10 (maximum); higher scores indicate greater tinnitus loudness. No response to nasal spray is defined as a decrease in VAS Score of less than 2, while a patient-reported improvement is defined as a decrease in VAS Score of more than 3.

Time frame: Baseline, Week 9

Data from ClinicalTrials.gov

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