Autism Study for Adolescents and Adults Struggling with Social and Communication Skills

Investigational Medication vs Placebo

$50 per completed visit


Study Specific Details:

  • Investigation Medication Placebo- This is a double blind study in which subjects are randomly place on investigational medication or Placebo. Dr. Handal will be able to find out what medication the subject is on in case of emergency.
  • 9 visits over a 10 week period.
  • Participants are reimbursed $50 for their time and travel at the end of each completed visit.
  • Inclusion
  • Exclusion
  • Male or Female ages 13-35.
  • Subjects meet DSM-V or ICD10 criteria for Autism. Diagnosis confirmed by ADOS-2 criteria at screening. An ADOS-2 completed w/in the past 24 months is acceptable if item responses are available for entry.
  • IQ composite score of 60or above, will be confirmed using K-BIT-2. A K-BIT-2 conducted within the past 6 months is also acceptable. 
  • Patient has an appropriate study partner.
  • Ability to tolerate venipuncture procedures for blood sampling.
  • ABA psychotherapy are allowed, but must be stable for at least 1 month prior to baseline and consistent throughout the study or has ended 30 days prior to baseline.
  • Must be able to swallow tablet whole with aid of water.
  • Must be able to wear a wrist watch throughout he study (provided).
  • Does not need to fast prior to screening.
  • IQ less than 60.
  • Patient has any vision abnormalities such as ptosis.
  • Patient has donated 1 or more units of blood (approx. 450 mL) or has had acute loss within the past 90 days.
  • Unstable psychiatric and/or neurological disorder that may interfere with the safety or efficacy endpoints.
  • Any medical condition that could potentially alter the absorption, metabolism, or excretions of the study drug.
  • Clinically significant suicidal ideation within the past 6 months.
  • Epilepsy is permitted if stable at the discretion of the investigator and consultation of the sponosr.
  • Patient has taken recreational or medically prescribed cannabis with the past month.
  • Alcohol or substance abuse/dependence within the past 6 months.
  • Has ever tested positive of hepatitis B. C or HIV.
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