Trial · NCT04210310

High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

NCT04210310, Phase 3, Terminated, NYU Langone Health; results first posted 2022-10-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. High Dose Oxytocin Nasal Spray for Treatment of Tinnitus. Trials, record NCT04210310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04210310

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
NCT number: NCT04210310
Status: Terminated
Phases: Phase 3
Enrollment: 33 participants, actual
Lead sponsor: NYU Langone Health
Conditions: Tinnitus
Interventions: Oxytocin, Placebo nasal spray
First posted: 2019-12-24
Last updated: 2022-10-05
Results first posted: 2022-10-05
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.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness	Baseline, Week 9	Study was terminated prematurely due to PI and study team departing the institution. Data were not collected for the primary outcome measure.

Source ClinicalTrials.gov

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	High-dose Intranasal Oxytocin	32
Overall Study	STARTED	Nasal Spray	1
Overall Study	COMPLETED	High-dose Intranasal Oxytocin	0
Overall Study	COMPLETED	Nasal Spray	0
Overall Study	NOT COMPLETED	High-dose Intranasal Oxytocin	32
Overall Study	NOT COMPLETED	Nasal Spray	1

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Mild Nasal Congestion	Respiratory, thoracic and mediastinal disorders	High-dose Intranasal Oxytocin	1	32
other	Mild Nasal Congestion	Respiratory, thoracic and mediastinal disorders	Nasal Spray	0	1
other	Atypical, intermittent chest pain	Cardiac disorders	High-dose Intranasal Oxytocin	1	32
other	Atypical, intermittent chest pain	Cardiac disorders	Nasal Spray	0	1
other	Mild Headache	Nervous system disorders	High-dose Intranasal Oxytocin	1	32
other	Mild Headache	Nervous system disorders	Nasal Spray	0	1
other	Intermittent Dizziness	Nervous system disorders	High-dose Intranasal Oxytocin	1	32
other	Intermittent Dizziness	Nervous system disorders	Nasal Spray	0	1
other	Bronchitis	Infections and infestations	High-dose Intranasal Oxytocin	1	32
other	Bronchitis	Infections and infestations	Nasal Spray	0	1

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	High-dose Intranasal Oxytocin	0	32
Total, all-cause mortality	Nasal Spray	0	1
Total, other adverse events	High-dose Intranasal Oxytocin	6	32
Total, other adverse events	Nasal Spray	0	1
Total, serious adverse events	High-dose Intranasal Oxytocin	1	32
Total, serious adverse events	Nasal Spray	0	1

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
High-dose Intranasal Oxytocin vs Nasal Spray: deaths from any cause	Trial comparisons
High-dose Intranasal Oxytocin vs Nasal Spray: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04210310

GET https://conductscience.org/api/trials/v1/NCT04210310/registered

API reference For AI assistants