Autism

Multiple questionnaires administered

Children's Hospital of Philadelphia

Medical Cannabis Registry and Pharmacology

The primary objective is to create a registry that will describe the natural history and landscape of medical cannabis and CBD use in the pediatric ASD population.

The PK profile of select medical cannabis products in pediatric patients with ASD will be assessed. PK sampling may be performed in the home or at a CHOP site. All Subjects will undergo PK sampling at predetermined times for the determination of cannabinoid concentrations based on the formulation that is being consumed (e.g. If a subject is taking only CBD, Tetrahydrocannabinol (THC) concentrations will not be measured). PK samples will be obtained either using a micro-sampling approach (home or CHOP) or from an indwelling catheter (CHOP site

Families will be informed of epidemiologic outcomes through an educational program for families that have participated in the research for those families who opt for this component. Although these are not research in nature, they are a direct result of the proposed research and are included in the protocol to demonstrate the study's deliverables.

Zelda Therapeutics

Oral cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] at 1 mg/kg cannabidiol per day, up-titrated until intolerance or to a maximum dose of 10 mg/kg CBD per day, divided to 3 daily doses, for 3 months.

Oral olive oil and flavors that mimic in texture and flavor the cannabinoids' solution.

Oral cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] at 1 mg/kg cannabidiol per day, up-titrated until intolerance or to a maximum dose of 10 mg/kg CBD per day, divided to 3 daily doses, for 3 months

Autistic Disorder

99% pure cannabidiol (CBD) and 99% pure Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.

Cannabinoids - 99% pure cannabinoids mix

Placebo

Whole plant extract enriched with cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) to achieve 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.

Cannabinoids - whole plant extract

Shaare Zedek Medical Center

Cannabinoids for Behavioral Problems in Children With ASD

Cannabinoids for Behavioral Problems in Autism Spectrum Disorder: A Double Blind, Randomized, Placebo-controlled Trial With Crossover.

This is a 24-item parent-rated measure of noncompliant behavior in children with ASD

This is a 7-point scale designed to measure overall improvement from baseline (CGI-I).

This is a 7-point scale designed to measure overall improvement from baseline

This is a 65 item, caregiver (pSRS) or teacher (tSRS) questionnaire, used to determine the severity of social deficit exhibited by participants with ASD. The SRS contains five subscales: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Autistic Mannerisms, which respectively measure the ability to recognize social cues, the ability to interpret social cues, the ability to use expressive verbal and nonverbal language skills, the ability to engage in social-interpersonal behaviors, and the tendency to display stereotypical behaviors and restricted interests characteristic of autism

This is a 13-item parent rated measure designed to assess the effect of interventions to control disruptive behavior in children with ASD on parenting stress.

This is a 24-item parent-rated measure of noncompliant behavior in children with ASD. Within subject differences between the placebo condition and the pure cannabinoids condition and between the whole plant extract condition and the pure cannabinoids condition.

Tolerability and adverse effects will be assessed using this modified Liverpool Adverse Events Profile (LAEP) that includes all 19 items of the original LAEP and another 15 items to cover all reported significant side effects of CBD and THC in former studies.

autism/femeln

Medical Cannabis Registry and Pharmacology

Cannabinoids for Behavioral Problems in Children With ASD

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