Autism Oxytocin Brain Project
Condition: Autism; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Intervention: 8 International Units (IU) of Oxytocin; 24IU of Oxytocin; 48IU of Oxytocin; Placebo
Intervention description: Participants will receive one dose of intranasal oxytocin at a dose of 8IU.; Participants will receive one dose of intranasal oxytocin at a dose of 24IU.; Participants will receive one dose of intranasal oxytocin at a dose of 48IU.; Participants will receive an intranasal placebo to match the oxytocin doses.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neuroscience

Summary:

      The main goal of the study is to look at the effects of intranasal oxytocin on the brain in
      Autism Spectrum Disorder (ASD). Oxytocin is a hormone that exists naturally in the body and
      the brain, affecting a wide range of social behaviors and emotions. The investigators will
      study the effects of different treatments (3 doses of oxytocin and one dose of placebo) on
      brain functional connectivity at rest in patients with ASD, using functional magnetic
      resonance imaging (fMRI). Investigators also seek to study how the effects of oxytocin
      treatment can be affected by genetic, immune and environmental factors.
    

Eligibility criteria:

        Inclusion Criteria for ASD Participants:

          -  Have an ASD diagnosis based on the Autism Diagnostic Observation Schedule (ADOS) and
             Autism Diagnostic Interview (ADI) criteria, gold standards of research-based autism
             diagnosis

          -  Intelligence quotient (IQ) > 70

          -  Normal or corrected-to-normal vision

        Exclusion Criteria for ASD Participants:

          -  Recent occurrence of seizures (past 5 years)

          -  Brain damage or head trauma (can be included at discretion of PI and sponsor)

          -  Color blind

          -  Cardiovascular disease

          -  Presence of a severe medical problem

          -  Severe mental retardation

          -  Alcoholism or substance abuse

          -  Asthma (can be included at the discretion of study physician/nurse practitioner if
             episodes are infrequent and no active problems at time of the study)

          -  Migraine headaches (at the discretion of the nurse practitioner or the study
             physician)

          -  Claustrophobia (at discretion of study physician/designee/PI)

          -  Pacemakers, cochlear implants, surgical clips or metal fragments

        Inclusion Criteria for Healthy Age-Matched Controls:

          -  IQ > 70

          -  Normal or corrected-to-normal vision

        Exclusion Criteria for Healthy Age-Matched Controls:

          -  History of seizures

          -  Neurological disorder

          -  Current psychiatric disorder

          -  Previous psychiatric disorder (can be included at discretion of PI)

          -  Current use of psychoactive drugs

          -  Previous use of psychoactive drugs (can be included at discretion of PI)

          -  Head trauma (can be included at discretion of PI)

          -  Alcoholism or substance abuse

          -  Cardiovascular disease

          -  Color blind

          -  Asthma (can be included at the discretion of study physician/nurse practitioner if
             episodes are infrequent and no active problems at time of the study)

          -  Migraine headaches (at the discretion of the nurse practitioner or the study
             physician)

          -  Claustrophobia (at discretion of study physician/designee/PI)

          -  Presence of a severe medical problem

          -  Severe mental retardation

          -  Pacemakers, cochlear implants, surgical clips or metal fragments