Can CBD tame severe autism behaviors? new study investigates
NCT ID NCT04517799
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether cannabidiol (CBD) can reduce severe behavior problems like aggression, self-harm, and repetitive actions in children with autism. About 42 boys aged 7-14 with severe autism and daily behavioral issues will receive both CBD and a placebo at different times to compare effects. The goal is to see if CBD can safely ease these challenging behaviors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
42 people
The number who actually took part.
- Started
-
Jun 2020
- Expected to finish
-
Dec 2025
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
7 to 14 years
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Autism are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of California San Diego
La Jolla, California, 92093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can wireless monitors make ER vitals easier for autistic children?
- Why do some children with autism struggle with balance?
- Brain zaps tested to calm emotional storms in autism
- Can an AI chatbot help autism caregivers find their way?
- Pregnancy and birth clues: what raises autism risk?
- Can virtual reality boost thinking skills in kids with autism?