High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

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

30 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Oxytocin Nasal Spray?

Research shows that oxytocin nasal spray can increase oxytocin levels in the body, which may influence social behaviors. It has been studied for conditions like autism, but results are mixed, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is intranasal oxytocin safe for humans?

Research shows that intranasal oxytocin is generally safe for humans, with most side effects being mild, such as nasal discomfort and tiredness. Severe side effects are rare, and studies suggest it is well tolerated in both children and adults. ^{1 2 6 7 8}

What is the purpose of this trial?

This trial is testing a nasal spray with high doses of oxytocin to help people with tinnitus. The goal is to see if this hormone can reduce the severity of the ringing in their ears and improve their quality of life.

Research Team

Lawrence Newman, MD

Principal Investigator

NYU Langone

Eligibility Criteria

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

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

Treatment Details

Interventions

• Oxytocin Nasal Spray
• Placebo Nasal Spray

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

No side-effects of single intranasal oxytocin administration in middle childhood. [2019]

2. Switzerland 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. [2018]

3. England 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. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

CSF and blood oxytocin concentration changes following intranasal delivery in macaque. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of reported adverse events of long-term intranasal oxytocin treatment for autism spectrum disorder. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. [2019]