Recruiting
Phase 2

Oxytocin

Sponsor:

Elizabeth Austen Lawson

Code:

NCT05754073

Conditions

Autism Spectrum Disorder

Bone Health

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

1. Intranasal oxytocin spray

2. Intranasal placebo spray

3. Intranasal Oxytocin spray

Study Details

Brief summary:

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). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.

Conditions

Autism Spectrum Disorder

Bone Health

Study ID

NCT05754073

Start date

Aug 1, 2023

Status verified date

Nov, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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:

1. Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, and other single gene defects that are syndromic and affect heart or bone density
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, other than calcium or vitamin D supplementation, such as specific anti-seizure medications (Phenytoin, Phenobarbital), oral glucocorticoids, hormonal contraceptive injection (Medroxyprogesterone acetate (Depo-Provera)
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 (QTc greater than or equal to 480 msec)
9. Active seizures within 6 months preceding the Screening visit or the Baseline visit
10. Subjects who are pregnant, lactating, or who refuse contraception if sexually active
11. Subjects who have had previous treatment with OXT (within 2 months of Randomization)
12. Subjects who are not able to cooperate with medication administration, blood drawing, or imaging procedures despite behavior training
13. Caregivers who are unable to speak English, be consistently present at study visits to report on symptoms or, per the judgement of the data collection team, are unable to comply with the protocol
14. Any significant illness, condition, medication, or medical device that the Investigator determines could interfere with study participation and impact data collection or subject safety

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1. Intranasal Oxytocin

Intranasal oxytocin spray (30 IU twice daily) for 12 months in the double-blinded phase followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase

placebo comparator: 2. Placebo

Intranasal placebo spray (30 IU twice daily (total 60 IU per day) for 12 months followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase

Interventions

1. Intranasal oxytocin spray

30 IU, twice daily for 12 months in the experimental arm in double-blinded phase

2. Intranasal placebo spray

30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase

3. Intranasal Oxytocin spray

30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase

Primary outcome measure

  • Difference between IN OXT vs placebo in 12-month change in whole body less head BMD Z-scores. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Madhusmita Misra, MD, MPH

434-924-9141abp6bd@uvahealth.org

Sarah Smith, DNP

617-726-3870mghboxstudy@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sarah Smith, DNP

617-726-3870mghboxstudy@mgb.org

Principal Investigator:

Elizabeth A Lawson, MD

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Andrea Marrs, MS

434-982-0871misralab@uvahealth.org

Principal Investigator:

Madhusmita Misra, MD,MPH

More Information

Sponsor

Elizabeth Austen Lawson

Last update posted

Mar 2, 2026

Last verified

Nov, 2025

Keywords

  • Autism spectrum disorder
  • Bone density
  • Oxytocin
  • Peri-pubertal children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Elizabeth Austen Lawson on 2026-03-02.