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NCT04517799Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
42 (actual)
First submitted
3 Aug 2020
Start date
1 Jun 2020
Primary completion date
30 Aug 2025
Lead sponsor
University of California, San Diego
Diseases
Autism
NCT number
NCT04517799

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 42
  • From 1 Jun 2020 to the primary completion date, 30 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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 recently participated in another investigational drug trial may be excluded

Other illness

  • 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 with an allergy to any components of the study drug

Other

  • children who might travel out of the area for a significant time during the study

Who the study is looking for

  • 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:
  • Aggressive and/or self-injurious (SIBs) behaviors occur almost daily (more than 6 times per week) in any situation (home, school, clinic, etc.).
  • 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)
  • 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.)
  • 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

Age in the registry: 7 years to 14 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California San Diego
Coordinator of this site? Confirm its status		La JollaUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.