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High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

Primary Purpose

Tinnitus

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo nasal spray
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

high-dose intranasal oxytocin

Nasal spray

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2019
Last Updated
September 7, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04210310
Brief Title
High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
Official Title
A Pilot, Proof of Concept, Placebo-controlled, Parallel Study of the Effects of High Dose Intranasal Oxytocin for the Treatment of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
PI departure from the institution.
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high-dose intranasal oxytocin
Arm Type
Experimental
Arm 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.
Arm Title
Nasal spray
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo nasal spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Newman, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

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