The Effects of Oxytocin in Obese Adults

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

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

61 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a nasal spray with oxytocin in adults to see if it can help with weight issues by affecting behaviors and metabolism. Oxytocin has been studied for its potential to reduce body weight and improve metabolic parameters in individuals.

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.

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

Research shows that intranasal oxytocin can increase oxytocin levels in the brain and blood, which may influence social behavior and cognition. However, its effectiveness in treating conditions like autism and Prader-Willi syndrome in children is still unclear, with mixed results in studies. ^{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 in both children and adults have not found consistent adverse events linked to its use. ^{1 3 6 7 8}

Research Team

Elizabeth A Lawson, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

BMI greater than or equal to 30 kg/m2

Timeline

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)

Treatment Details

Interventions

• Oxytocin Nasal Spray
• Placebo

Participant Groups

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+

Findings from Research

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]

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 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. 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]

2. 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]

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

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]