Oxytocin Nasal Spray for Obesity

Overseen By Elizabeth Lawson, MD, M.M.Sc.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Metabolism drugs

Disqualifiers: Cardiovascular, Gastrointestinal, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an oxytocin nasal spray can aid in weight management for obese adults. Oxytocin, a hormone, might influence weight by affecting behaviors and metabolism. Participants will receive either the oxytocin spray or a placebo to compare results. This trial may suit individuals with a BMI of 30 or higher who haven't recently changed medications or diets. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that affect metabolism, glucose, or appetite, except for Metformin if your dose and weight have been stable for at least 3 months. If you've changed medications in the last 4 weeks, you may not be eligible.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that using oxytocin as a nasal spray is generally safe. A review of 38 studies found that most did not report serious side effects. Some studies mentioned rare issues like aggression and seizures, but these also occurred in placebo groups. Another study found no major problems with doses between 24 to 72 IU, suggesting that oxytocin is well-tolerated by most people. However, as with any treatment, risks exist, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for obesity, which often include lifestyle changes and medications that target metabolism or appetite, oxytocin nasal spray offers a novel approach by leveraging the hormone oxytocin, known for its role in social bonding and appetite regulation. Researchers are excited about oxytocin because it may help reduce food intake and promote weight loss through its unique mechanism of action on the brain, potentially offering an alternative for individuals struggling with obesity. Additionally, the nasal spray delivery method is non-invasive and convenient, making it easy for users to incorporate into their daily routines.

What evidence suggests that intranasal oxytocin could be an effective treatment for obesity?

Research has shown that intranasal oxytocin, which participants in this trial may receive, offers potential benefits, particularly in reducing stress and enhancing social interactions. One study found that a 24 IU dose of intranasal oxytocin significantly lowered stress levels when individuals felt judged by others. Another study demonstrated improvements in social skills, such as better eye contact. However, not all studies have found it more effective than a placebo for other outcomes. While oxytocin shows promise in certain areas, its effectiveness can vary depending on the situation. Participants in this trial may receive either the oxytocin nasal spray or a placebo nasal spray. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth A Lawson, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

BMI greater than or equal to 30 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

A 2-part baseline visit to establish initial measurements and conditions

1 week

2 visits (in-person)

Treatment

Participants receive intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks

8 weeks

Visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin Nasal Spray
• Placebo

How Is the Trial Designed?

Group I: oxytocin Experimental Treatment 1 Intervention

oxytocin nasal spray (24 IU nasal spray, 4 times per day for 8 weeks)

Group II: placebo Placebo Group 1 Intervention

placebo nasal spray (4 times per day for 8 weeks)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

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]

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 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]

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]

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]

Citations

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Results showed that on all primary and secondary outcomes, there was no benefit of oxytocin nasal spray treatment in comparison to placebo.

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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 ...

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Intranasal oxytocin is attracting attention as a potential treatment for several brain disorders due to promising preclinical results.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9607840/

The effect of oxytocin nasal spray on social interaction in ...

In humans, administration of oxytocin has been found to improve a range of outcomes associated with social responsiveness, including eye gaze [9] ...

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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 ...

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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.

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pmc.ncbi.nlm.nih.gov

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

Safety and tolerability of chronic intranasal oxytocin in older men

Most studies evaluating the safety and tolerability of intranasal oxytocin (OT) have not reported consistent adverse events (AEs), ...

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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.

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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 ...

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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).