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High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04210310
Recruitment Status : Terminated (PI departure from the institution.)
First Posted : December 24, 2019
Results First Posted : October 5, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Oxytocin Other: Placebo nasal spray Phase 3

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus
Actual Study Start Date : January 15, 2020
Actual Primary Completion Date : May 10, 2022
Actual Study Completion Date : May 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: high-dose intranasal oxytocin
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.
 Drug: Oxytocin
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
Other Name: Pitocin
Placebo Comparator: Nasal spray
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.
 Other: Placebo nasal spray
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness [ Time Frame: Baseline, Week 9 ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04210310


Locations
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United States, New York
222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health
New York, New York, United States, 10017
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Lawrence Newman, MD NYU Langone
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
Study Protocol and Statistical Analysis Plan  [PDF] November 16, 2021

More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04210310    
Other Study ID Numbers: 19-01381
First Posted: December 24, 2019    Key Record Dates
Results First Posted: October 5, 2022
Last Update Posted: October 5, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Lawrence.newman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs