Autism Oxytocin Brain Project

This study consists of investigating the effects of several doses of acute administration of
intranasal oxytocin on brain activity in adults with Autism Spectrum Disorder (ASD). There is
increasing evidence for the role of intranasal oxytocin (IN-OT) in enhancing social skills in
ASD. Nevertheless, there is still a need of determining target engagement for oxytocin's
action on brain and behavior. Here, investigators are studying the effects of different doses
of IN-OT on the modulation of behavioral outcomes and neural responses in a double blind
crossover study in individuals with ASD.

The aims of the research are to:

1. Study the effects of IN-OT doses on the modulation of brain functional connectivity
between key socio-emotional brain regions during resting state in ASD

2. Study the effects of IN-OT doses on the BOLD activity of key emotional and perceptual
brain networks in response to social cues (such as faces)

3. Study the effects of IN-OT on the BOLD activity of brain regions during an interactive
social environment (ball game) in ASD

Investigators will compare the neuroimaging and behavioral results of individuals with ASD to
control healthy males who will receive intranasal placebo. Investigators are also
investigating the role of genetic factors, behavioral or clinical sub-groups of ASD, immune
and environmental factors in modulating the effect of IN-OT on brain and behavior.

Participants will undergo 4 clinical visits during which they receive various randomly
assigned doses of intranasal oxytocin and placebo. Both participants and the experimenter
will be blind to the type of the treatment administered.

There will be only one visit for healthy controls who will all receive placebo spray. The
visit for healthy controls will be conducted in a single-blind design. The experimenter will
be aware that the subject is receiving placebo. However, the participant will be told that he
might receive oxytocin or placebo.

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

- 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