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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: Wholistic Research and Education Foundation
• Treatments: Cannabidiol; Epidiolex

Criteria

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