High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus

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.

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.