High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

NYU Langone Health

Status and phase: Terminated; Phase 3

Conditions: Tinnitus

Treatments: Other: Placebo nasal spray; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT04210310

19-01381

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

high-dose intranasal oxytocin

Experimental group

Description:

Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.

Treatment:

Drug: Oxytocin

Nasal spray

Placebo Comparator group

Description:

Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.

Treatment:

Other: Placebo nasal spray