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ACTIVE NOT RECRUITING

NCT04517799

PHASE2

Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

Summary

There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.

Official title: A Double-Blind, Crossover Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism

Key Details

Gender

MALE

Age Range

7 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-06-01

Completion Date

2025-12-31

Last Updated

2025-09-30

Healthy Volunteers

Conditions

Autism Autism Spectrum Disorder

Interventions

DRUG

Epidiolex

While in the intervention arm subjects will receive EPIDIOLEX, an oral purified CBD solution developed by GW Pharmaceuticals. The formulation is a 100 mg/mL solution, which allows for easy dose titration and administration even to young children. EPIDIOLEX is naturally-derived CBD, and has been found to have a purity of over 98%. The solution includes a sweetener to make it palatable. Dosing is dependent upon each subject's weight. The dosage will be titrated over time as follows: Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change.

DRUG

placebo oral solution

GW has developed a placebo that is identical in color and taste, and will be administered in the same volume as the CBD, so that parents and investigators should not be able to detect differences between the 2 treatments. Dosing is dependent upon each subject's weight. The dosage will be titrated as follows: Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change.

Inclusion Criteria: * Boys ages 7-14 years * Confirmed diagnosis of autism based on ADOS testing * Autism severity assessed as severe with substantial behavioral problems Severity of symptoms will be based on a number of criteria: 1. Aggressive and/or self-injurious (SIBs) behaviors occur almost daily (more than 6 times per week) in any situation (home, school, clinic, etc.). 2. Frequent (daily), persistent (lasting at least 5-10 minutes and repeated through the day) stereotypies (repetitive behaviors such as hand flapping, running in circles, jumping repeatedly, waving fingers in front of eyes) 3. Pervasive hyperactivity (child is so physically active that he cannot sit for meals or school work, is moving all the time, jumping off furniture, climbing onto furniture, etc.) 4. One of more of the above activities is deemed to contribute significantly to child's inability to function by parental report and with clinician agreement based on history and/or direct observation Exclusion Criteria: * the presence of epilepsy * a known genetic condition such as tuberous sclerosis * other significant health issues such as cardiac disease, presence of known congenital brain malformation, or a history of central nervous system infection. * children who are on anticonvulsant medications such as clobazam or valproic acid will also be excluded because of potential drug-drug interactions. At the time of screening, each child's medication list will be checked for drugs that are known to cause interactions with cannabidiol. * children with an allergy to any components of the study drug * children who are taking CBD from another source, unless parents are willing to stop the treatment for at least 4 weeks prior to entering the study. CBD and other cannabinoid blood levels will be performed at baseline and if CBD is detected in the blood, the child will be not be included in the study. * children who might travel out of the area for a significant time during the study * children who recently participated in another investigational drug trial may be excluded

Locations (1)

University of California San Diego

La Jolla, California, United States