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NCT05754073RECRUITINGIRB Ready

Oxytocin Effects on Bone in Children with Autism Spectrum Disorder

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Sponsored by Elizabeth Austen Lawson

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 96 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily).

Who Can Participate

Inclusion Criteria

Ages 6 to 18 years old at Randomization 2. BMI greater than or equal to the 5th percentile 3. Expert clinical diagnosis of ASD 4. Availability of parent/guardian to provide informed consent

Exclusion Criteria

Fragile X, tuberous sclerosis, and other single gene defects that are syndromic 2. Other conditions that may contribute to low bone density (e.g., hypogonadism) 3. Medications that may impact bone other than calcium or vitamin D supplementation 4. Hyponatremia 5. Liver enzymes (AST, ALT, and Bilirubin) more than three times the upper limit of the normal range 6. Estimated glomerular filtration rate (eGFR) less than 60 7. Substance use disorder within the last 6 months 8. History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT 9. Active seizures within 6 months preceding the Screening visit or the Baseline visit 10. Subjects who are pregnant, lactating, or

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

96 participants

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Age Range

6 Years - 18 Years

Gender

ALL

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Sponsor

Elizabeth Austen Lawson

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Boston

Massachusetts

Location available
RECRUITING

Charlottesville

Virginia

Location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

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Looking for Autism Spectrum Disorder Treatment in Boston?

Join others in Massachusetts exploring innovative treatment options through clinical research

Autism Spectrum Disorder Treatment Options in Boston, Massachusetts

If you're searching for Autism Spectrum Disorder treatment in Boston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Boston, Charlottesville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Autism Spectrum Disorder. All study-related care is provided at no cost to participants.

Local Sites
2 locations in Massachusetts
Now Enrolling
Up to 96 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Autism Spectrum Disorder?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Autism Spectrum Disorder

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Autism Spectrum Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05754073. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.