Oxytocin Nasal Spray for Tinnitus

No longer recruiting at 1 trial location

Overseen By Jacqueline Okolie, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Oxytocin nasal spray

Disqualifiers: Migraines, Pulmonary edema, CHF, others

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a high-dose oxytocin nasal spray can reduce the severity of tinnitus, a ringing or buzzing sound in the ears. Participants will receive either the oxytocin spray or a placebo (a non-active substance) and will use it four times a day. The goal is to determine if the spray can make tinnitus less disruptive to daily life. The trial seeks individuals who have experienced tinnitus for more than six months, find it quite loud and bothersome, and have not received treatment for it in the past six months. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could enhance tinnitus treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using oxytocin as a nasal spray is generally safe. A review of 38 studies over the last 20 years found no serious side effects linked to its use. One study on older men found that the spray did not cause any major health problems and was well-accepted.

While some studies reported a few serious side effects, these were rare. For example, both the oxytocin and placebo groups experienced aggression and seizures, making it unclear if oxytocin was the cause. Overall, the evidence suggests that using oxytocin as a nasal spray is a safe option for further research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for tinnitus, which often involve sound therapy or medications like antidepressants and anticonvulsants, the oxytocin nasal spray offers a novel approach by utilizing the hormone oxytocin. Oxytocin is known for its role in social bonding and reducing stress, and researchers are excited about its potential to calm the auditory pathways associated with tinnitus. The nasal spray delivery method is also unique, providing a direct and easy way to administer the treatment multiple times a day, which could lead to more consistent results in managing symptoms.

What evidence suggests that high-dose intranasal oxytocin might be an effective treatment for tinnitus?

Research has shown that a nasal spray with oxytocin can raise oxytocin levels in the blood, potentially aiding certain health issues. Some studies suggest that oxytocin can lower stress in social situations. In this trial, participants will receive either a high-dose intranasal oxytocin spray or a placebo nasal spray. Although direct evidence for oxytocin's use in treating tinnitus is limited, researchers are exploring its potential because it might affect the brain and stress levels. These effects could help reduce the perceived severity of tinnitus by calming the brain's reaction to sound. However, more research is needed to confirm its effectiveness for tinnitus. ^{6 7 8 9 10}

Who Is on the Research Team?

Lawrence Newman, MD

Principal Investigator

NYU Langone

Are You a Good Fit for This Trial?

Inclusion Criteria

People who have continuous tinnitus for at least six months.

People being studied must have had a normal examination of the ears and throat area within the past year, and no evidence of ear infection or inflammation

People who want to participate in this study must have a loudness rating of tinnitus of more than 4 out of 10.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-dose intranasal oxytocin or placebo nasal spray for tinnitus treatment

9 weeks

Participants use nasal spray 4 times daily

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin Nasal Spray
• Placebo Nasal Spray

How Is the Trial Designed?

Group I: high-dose intranasal oxytocin Experimental Treatment 1 Intervention

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.

Group II: Nasal spray Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a double-blind, placebo-controlled trial involving 50 male participants aged 12 to 18 with autism spectrum disorders, oxytocin nasal spray showed no significant improvement in social behavior compared to placebo after 8 weeks of treatment.

Despite the lack of clinical efficacy, caregivers who believed their children received oxytocin reported perceived improvements, suggesting that expectations may influence treatment outcomes; however, oxytocin was well tolerated with no increased side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial. Guastella, AJ., Gray, KM., Rinehart, NJ., et al.[2015]

Intranasal administration of oxytocin (OT) effectively increases its concentration in the cerebrospinal fluid (CSF) and plasma, suggesting it can reach central nervous system targets.

Both delivery methods (intranasal spray and nebulizer) were effective in elevating CSF OT levels, with the nasal spray showing greater increases in plasma OT concentration compared to the nebulizer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CSF and blood oxytocin concentration changes following intranasal delivery in macaque. Dal Monte, O., Noble, PL., Turchi, J., et al.[2021]

Intranasal oxytocin has been studied in 261 children across various trials, primarily focusing on autism spectrum disorder (ASD) and Prader-Willi syndrome (PWS), but results for efficacy in ASD are mixed and there is currently no evidence supporting its benefit for PWS.

Adverse events related to intranasal oxytocin are mostly mild, with few moderate or severe cases reported, indicating a generally safe profile; however, monitoring and reporting of these events are inconsistent, highlighting the need for improved adherence and safety protocols in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the Safety, Efficacy and Mechanisms of Delivery of Nasal Oxytocin in Children: Therapeutic Potential for Autism and Prader-Willi Syndrome, and Recommendations for Future Research. DeMayo, MM., Song, YJC., Hickie, IB., et al.[2018]

A systematic review of five randomized controlled trials involving 223 participants found that long-term use of intranasal oxytocin in treating autism spectrum disorder (ASD) is generally well tolerated, with common side effects like nasal discomfort and tiredness not significantly linked to the treatment.

While some severe adverse events were reported, such as aggression and seizures, the overall safety profile suggests that intranasal oxytocin is safe for use in the ASD population, warranting further research to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. Cai, Q., Feng, L., Yap, KZ.[2018]

This study is the first double-blind randomized controlled trial examining the side effects of intranasal oxytocin in 100 elementary school-aged children, showing that it is likely safe with no significant side effects reported.

Most side effects were mild and resolved within 24 hours, indicating that intranasal oxytocin is well tolerated in children aged 8-12 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No side-effects of single intranasal oxytocin administration in middle childhood. Verhees, MWFT., Houben, J., Ceulemans, E., et al.[2019]

A study involving 95 generally healthy older men found that chronic intranasal oxytocin (OT) administration for 4 weeks was safe and well-tolerated, with no significant adverse effects on cardiovascular or metabolic health.

The incidence and severity of adverse events were low and similar between the OT and placebo groups, suggesting that OT does not increase the risk of side effects in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial. Rung, JM., Horta, M., Tammi, EM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4332939/

A Double-Blind Randomized Controlled Trial of Oxytocin ... In conclusion, this study demonstrated that oxytocin, combined with SCT, did not result in significant improvements in social cognition, symptom severity, or ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0143417912000686

Oxytocin plasma concentrations after single intranasal ... Results gave evidence for a substantial rise of oxytocin plasma levels 30 min after intranasal administration, observed in 7 of 8 participants.

3. nature.com nature.com/articles/s41598-025-95148-x

Nasal dominance potentiates intranasal oxytocin's ... We show that 24 IU of intranasal oxytocin significantly reduces social-evaluative stress and is significantly more effective in this stress ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8406061/

Efficacy of Self-Administered Intranasal Oxytocin on Alcohol ... Short Summary: Intranasal oxytocin did not significantly reduce alcohol craving or relapse compared with placebo the first four weeks after detoxification in ...

5. fertstert.org fertstert.org/article/S0015-0282%2815%2900432-X/fulltext

Effect of long-term intranasal oxytocin on sexual ... Our data demonstrate that both intranasal oxytocin and placebo improve female sexual dysfunction and depressive symptoms in pre- and postmenopausal women over ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306453011000862

A review of safety, side-effects and subjective reactions to ... This paper reviewed side effects and safety data on the use of intranasal oxytocin in 38 controlled trials conducted over the last 20 years.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8115997/

Safety and tolerability of chronic intranasal oxytocin in older men Chronic intranasal OT appears safe and well-tolerated in generally healthy older men. These findings provide support for continued human research.

8. merck.com merck.com/docs/product/safety-data-sheets/ah-sds/Oxytocin%20Formulation_AH_NZ_6N.pdf

Oxytocin Formulation Retain and dispose of contaminated wash water. Local authorities should be advised if significant spillages. Page 3. SAFETY DATA SHEET.

9. journals.sagepub.com journals.sagepub.com/doi/10.1177/10398562241291335

Oxytocin in old age psychiatry: A systematic review of the ... Compared to placebo intranasal oxytocin was not significantly associated with severe adverse outcomes in doses ranging from 24 to 72 IU after ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pcn.12627

Systematic review and meta‐analysis of reported adverse ... Five severe adverse events were reported, namely aggression (one in placebo, two in oxytocin) and seizures (one in placebo, one in oxytocin).