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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Aug 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of cannabidiol, a compound found in cannabis, to see if it can help reduce severe behavioral problems in boys aged 7 to 14 with autism. These behaviors can include aggression, self-harm, repetitive actions, and extreme hyperactivity, which can make it difficult for children to function at home or school. The trial is looking for boys who have been diagnosed with autism and show significant behavioral challenges, as confirmed by specific assessments.

To participate, boys must be between 7 and 14 years old and have a confirmed autism diagnosis with severe behavioral issues. However, some children may not be eligible, especially if they have certain health conditions like epilepsy or are taking specific medications that could interact with cannabidiol. If chosen for the study, participants will receive cannabidiol and will be monitored closely to see how it affects their behaviors. This trial is currently active but not recruiting new participants. It’s important for families to know that all potential participants will be carefully assessed to ensure their safety throughout the study.

Gender

MALE

Eligibility 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