High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

• ClinicalTrials.gov Identifier: NCT04210310
• Recruitment Status: Terminated
• First Posted: December 24, 2019
• Results First Posted: October 5, 2022
• Last Update Posted: October 5, 2022
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Tinnitus
• Interventions: Drug: Oxytocin; Other: Placebo nasal spray
• Enrollment: 33

Participant Flow

Recruitment Details
Pre-assignment Details	The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

Arm/Group Title	High-dose Intranasal Oxytocin	Nasal Spray
Arm/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. 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	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. 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.
Period Title: Overall Study
Started	32	1
Completed	0	0
Not Completed	32	1
Reason Not Completed
Lost to Follow-up	32	1

Baseline Characteristics

Arm/Group Title		High-dose Intranasal Oxytocin	Nasal Spray	Total
Arm/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. 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	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. 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.	Total of all reporting groups
Overall Number of Baseline Participants		32	1	33
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	32 participants	1 participants	33 participants
		59.9 (11.5)	66 (0)	60.1 (11.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	32 participants	1 participants	33 participants
	Female	5 15.6%	0 0.0%	5 15.2%
	Male	27 84.4%	1 100.0%	28 84.8%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	32 participants	1 participants	33 participants
		32	1	33

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study was terminated prematurely due to PI and study team departing the institution. Data were not collected for the primary outcome measure.

Arm/Group Title	High-dose Intranasal Oxytocin	Nasal Spray
Arm/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. 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	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. 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.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	6 Weeks
Adverse Event Reporting Description	Every other week, participants will receive a phone call from study staff to discuss their experience using the study drug and monitor for any adverse effects.
Arm/Group Title	High-dose Intranasal Oxytocin	Nasal Spray
Arm/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. 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	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. 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.
All-Cause Mortality
	High-dose Intranasal Oxytocin	Nasal Spray
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/32 (0.00%)	0/1 (0.00%)
Serious Adverse Events
	High-dose Intranasal Oxytocin	Nasal Spray
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/32 (3.13%)	0/1 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea †	1/32 (3.13%)	0/1 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	High-dose Intranasal Oxytocin	Nasal Spray
	Affected / at Risk (%)	Affected / at Risk (%)
Total	6/32 (18.75%)	0/1 (0.00%)
Cardiac disorders
Atypical, intermittent chest pain †	1/32 (3.13%)	0/1 (0.00%)
Gastrointestinal disorders
Diarrhea †	1/32 (3.13%)	0/1 (0.00%)
Infections and infestations
Bronchitis †	1/32 (3.13%)	0/1 (0.00%)
Nervous system disorders
Mild Headache †	1/32 (3.13%)	0/1 (0.00%)
Intermittent Dizziness †	1/32 (3.13%)	0/1 (0.00%)
Renal and urinary disorders
Increased urination †	1/32 (3.13%)	0/1 (0.00%)
Respiratory, thoracic and mediastinal disorders
Mild Nasal Congestion †	1/32 (3.13%)	0/1 (0.00%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

Study was prematurely terminated due to PI/Study Team departure from institution. No outcome measure data collected or analyzed. All participants lost to follow-up.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Lawrence Newman, MD
• Organization: NYU Langone Health - Preston Robert Tisch Center for Men's Health
• Phone: 646-754-2000
• EMail: Lawrence.Newman@nyulangone.org

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04210310
• Other Study ID Numbers: 19-01381
• First Submitted: December 12, 2019
• First Posted: December 24, 2019
• Results First Submitted: August 4, 2022
• Results First Posted: October 5, 2022
• Last Update Posted: October 5, 2022