Cannabidiol for ASD Open Trial

Exclusion Criteria

• •History or current evidence of significantly impaired liver function, defined as 1) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 × upper limit of normal (ULN); 2) ALT or AST \> 3 × ULN with concomitant total bilirubin \> 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia
• •History of active seizure disorder or epilepsy; patients seizure free for \>5 years off of antiepileptic drugs and other than uncomplicated febrile seizures are not excluded
• •Exposure to any investigational agent in the 30 days prior to initiation of trial
• •Treatment with CBD or other cannabinoid within the previous two months
• •Current use of medications metabolized primarily by CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, or CYP2D6 isoenzymes. Methylphenidate is not contraindicated.
• •History of drug abuse including marijuana/cannabis use in the past 3 months
• •Positive urine sample results from drug screening indicating presence of the following drugs: THC, opiates, methamphetamine, or cocaine
• •Diagnosis of a known genetic disorder (e.g., Prader-Willi Syndrome, Angelman Syndrome, etc.).
• •Active suicidality (ideation and plan) is present
• •A current psychiatric diagnosis of bipolar disorder, major depressive disorder (MDD), psychosis, schizophrenia, or post-traumatic stress disorder (PTSD)
• •Pregnant or lactating patients or patients who will not agree to be abstinent or use contraception
• •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
• •Diagnosis of Rett Syndrome or Childhood Disintegrative Disorder or marked sensory impairment such as deafness or blindness
• •Subjects who have had changes in allied health therapies, behavioral or educational interventions within 4 weeks prior to initiation of trial, other than those associated with school holidays
• •Subjects who have had changes in non-exclusionary psychotropic medications within 4 weeks of initiation of trial