Understanding the Benefits of Cannabidiol in Children with Autism Spectrum Disorder

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Pervasive Developmental Disorders
  • Age: Between 7 - 17 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are between the ages of 7 and 17.9 years old
    2. Subjects who have a diagnosis of ASD and ADHD
    3. Subjects who meet specified requirements on psychological measures at screening
    4. Subjects who have physical exam and laboratory results that are within normal range for their age
    5. Subjects whose parent/legal guardian is able to consent for their participation and complete assessments regarding the child's development and behavior throughout the study
    6. Subjects who have fluent speech, broadly average intelligence, and who are able to provide assent

You may not be eligible for this study if the following are true:

    1. Subjects with a history of active seizure disorder or epilepsy
    2. Subjects with a history or current evidence of significantly impaired liver function
    3. Subjects who have taken any investigational agent in the 30 days prior to initiation of the CBD trial
    4. Subjects with prior chronic treatment with CBD or other cannabinoid
    5. Subjects with current use of medications metabolized primarily by specific liver isoenzymes that are affected by CBD
    6. Subjects who have a history of drug abuse including marijuana/cannabis use in the past 3 months
    7. Subjects with positive urine sample results from initial and confirmatory drug screening indicating presence of the following drugs: cannabinoids, opiates, methadone, cocaine, and PCP
    8. Subjects who have active suicidality (thoughts of suicide and a plan)
    9. Subjects with a current psychiatric diagnosis of bipolar disorder, major depressive disorder, psychosis, schizophrenia, or post-traumatic stress disorder
    10. Subjects who are pregnant or breastfeeding
    11. Subjects with a medical condition that severely impacts the subject's ability to participate in the study, interferes with the conduct of the study, confounds interpretation of study results or endangers the subject's well-being
    12. Subjects with a diagnosis of Rett Syndrome, Childhood Disintegrative Disorder or marked sensory impairment such as deafness or blindness
    13. Subjects who have had changes in allied health therapies, behavioral or educational interventions within 4 weeks prior to initiation of the trial, other than those associated with school holidays
    14. Subjects who have had changes in their allowed psychotropic medications within 4 weeks of initiation of the trial

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.