Autism Study for Children and Teens with CBD Oil

CBD Oil vs Placebo

Study Specific Details:

CBD Oil vs Placebo- This is a double blind study in which subjects are randomly placed on CBD Oil vs Placebo. Dr. Handal will be able to find out what medication the subject is on in case of emergency.
This study will concentrate on reducing symptom severity in children and adolescents with Autism.
8-week study with 3 office visits and 6 visits being remote visits.
Participants are reimbursed $50 for their time and travel at the end of each completed visit.

Children and Adolescents ages 6-17
IQ of 70 or higher.
Subject with a primary DSM-V diagnosis of Autism.
Diagnosis confirmed by ADOS-2 criteria at screening or conducted within 2 years of screening by a qualified assessor.
CGI-I, CGI-S and ABC subscales will be administered to determine irritability eligibility and overall condition.
The VABS-3 will be administered to determine social and communication skills.
Medications or interventions for ASD related symptoms must have been stable for 4 weeks prior to screening and consistent throughout the study.

Has a diagnosis other than ASD that is primary.
Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or major depression (unless in remission).
Seizures in the past 24 weeks.
Has a progressive neurological condition.
Patient has had brain surgery or traumatic brain injury within the past year.
Any history of suicidal behavior (lifelong) or any suicidal ideation in the past 4 weeks.
Any known or suspected history of alcohol or substance abuse.
Currently taking more than 2 AED's
Changes in anticonvulsive therapy within the last 12 weeks.

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