Study Name: Brain Imaging of Intranasal Oxytocin Treatment in Autism
PI: Linmarie Sikich, MD and Gabriel Dichter, PhD
Sponsor: National Institute of Mental Health (NIMH) K23 MH081285
Contact person: Lindsey Hazzard
The ASPIRE team is currently conducting a research study involving children and adolescents (ages 6 - 18 years) with a diagnosis of an autism spectrum disorder. This study is looking at the effects of an investigational medication on the brain. Oxytocin (nasal spray) is thought to help with social behaviors. This study is looking specifically at the effects of oxytocin vs. placebo on various brain activities. Participants will receive either one dose of oxytocin or one dose of placebo (saline solution with no medicine) followed by brain scans and behavioral assessments.
Participants will be provided with free and convenient parking. Study medication and research related services will be free of charge, and participants will be compensated per study visit that they complete.
Major Inclusion Criteria
- Between 6 and 18 years old, inclusive
- Have a clinical diagnosis of an autism spectrum disorder confirmed according to the Autism Diagnostic Observation Scale (ADOS, Lord et al., 1989). Diagnosis may be also be confirmed using the Autism Diagnostic Interview – Revised (ADI-R).
Major Exclusion Criteria
- History of claustrophobia
- Implanted medical devices, implanted metal debris, shrapnel, certain tattoos, or permanent makeup that is contraindicated for MRI. Participants fill out a detailed questionnaire on the day of scanning to identify potential MRI risks
- Pregnancy/Nursing because of the unknown effects of oxytocin to unborn babies and/or nursing infants. All females of child-bearing potential will be administered a serum pregnancy test at screening and at any point during the study at physician discretion. Refusal to undergo a pregnancy test will result in exclusion from the study. We will share results of pregnancy test with the subject’s legal guardian.
- Use of hormonal birth control
Site of study
2218 Nelson Highway Suite 1 Chapel Hill, NC 27517 and BIAC at Duke Hospital, Erwin Rd, Durham, NC
Date enrollment closes