Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04210310
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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 Not Applicable

Detailed Description:
This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
Drug Information available for: Oxytocin

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.




Primary Outcome Measures :
  1. Change of tinnitus loudness as measured by Visual Analogue Scale (VAS) when compared to placebo [ Time Frame: Visit Week 4 (8 wks) ]
    Comparing endpoints of Visual Analogue Scale (VAS) of all 30 subjects at 4th week of treatment with active drug vs baseline. The primary outcome measure for this study will be a greater than 50% improvement in tinnitus loudness on the Visual Analog Scale (VAS). No response to nasal spray is defined as a decrease in VAS < 2, and a patient reported improvement is defined as an increase in VAS > 3. No minimum and maximum values are defined.The higher the score indicates more improvement in tinnitus loudness.

  2. Comparative change of tinnitus loudness of same subjects given placebo vs active drug [ Time Frame: Visit Week 5 (8 wks) , Visit Week 9 (16wks) ]
    Comparative endpoint during the cross-over phase of VAS at the 4th week between the 15 subjects who received placebo vs the 4th week of the single blinded phase for the same subjects . This endpoint compares the 15 patients that were switched from active to placebo and compares their response on placebo with their response on placebo and compare them to the 15 subjects that remained on active drug during the entire study.

  3. Comparative change in tinnitus loudness using active drug alone or active drug and placebo [ Time Frame: Visits Week 5 (8 wks), Week 6 (10wks), Week 7 (12wks), Week 8 (14wks), Week 9 (16 wks) ]
    A parallel group analysis to compare both arms in the last week of the double-blind phase-comparing those 15 who were on active throughout the entire study to those that started on active and changed over to placebo.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.

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


Contacts
Layout table for location contacts
Contact: Lawrence Newman, MD 646 754-2000 Lawrence.Newman@NYUlangone.org
Contact: Jacqueline Okolie 646 754-2000 Jacqueline.Okolie@nyulangone.org

Locations
Layout table for location information
United States, New York
222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health Recruiting
New York, New York, United States, 10017
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Lawrence Newman, MD NYU Langone
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04210310    
Other Study ID Numbers: 19-01381
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs