CBD oil studied as a treatment for severe behavioral issues in kids with intellectual disability
NCT ID NCT04821856
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether cannabidiol (CBD) oil can reduce severe behavioral problems in children aged 6-18 with intellectual disability. 132 participants received either CBD or a placebo for 8 weeks. The main goal was to see if CBD improves irritability and other challenging behaviors, as measured by a parent questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cannabidiol (CBD) oil
- What this could lead to
- If it works, this could provide a new treatment option for severe behavioral problems in children with intellectual disability.
- What could go wrong
- This is a phase 2 trial with a moderate size (132 participants). The results may not be strong enough to confirm effectiveness, and CBD may cause side effects or interact with other medications.
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
-
132 people
The number who actually took part.
- Started
-
May 2021
- Finished
-
Aug 2025
- 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
-
6 to 18 years
- Sex
-
Anyone
- 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: 1. Males and females aged 6 - 18 years of age; 2. DSM-5 diagnosis of intellectual disability (ID): 1. Full scale IQ \< 70 on standardized cognitive assessment. Testing results must be sighted by the investigators and performed within two years of enrollment. In the event that records of prior testing are unavailable or the assessment was more than 2 years prior, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence-II. 2. Deficit in adaptive function (basis for severity rating of ID in DSM-5) in at least one activity of life on the Vineland Adaptive Behavior Scales (derives scores in Communication, Daily Living Skills and Socialization domains, and a Global Adaptive score). If records of prior testing are unavailable or the assessment was more than 2 years prior, this will be completed by the parent or guardian. 3. SBP: Defined as scores of: 1. 18 or higher on the Aberrant Behavior Checklist-Irritability subscale (ABC-I), and 2. moderate or higher on the Clinical Global Impressions-Severity scale; 4. No changes in either medication or other interventions in the 4 weeks prior to randomization, and intention to remain on same dose for the duration of the study; 5. Written informed consent from parent or legal guardian; 6. Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator. Exclusion Criteria: 1. Non-English speaking parents; 2. Psychosis; 3. Taking clobazam, mTOR inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \>20mg/day, escitalopram \>10mg/day.; 4. Abnormal liver function tests: defined as ALT \> twice ULN; 5. Abnormal renal function tests: defined as creatinine \> ULN 6. Current use of medicinal cannabis, or use in the 4 weeks prior to screening; 7. Pregnant or intending to become pregnant during the study, or breastfeeding; 8. Known allergy to cannabidiol or cannabis products
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Child behavior problem 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
-
Monash Children's Hospital
Clayton, Victoria, 3168, Australia
-
Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, 3052, Australia
-
The Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can practicing parenting in virtual reality calm Kids' aggression?
- Brain zaps tested to calm emotional storms in autism
- VR Role-Play therapy aims to help kids tame anger
- AI chatbot app aims to ease parental stress
- Can a WhatsApp chatbot help keep children safer?
- Tiny exercise bursts might sharpen minds in intellectual disability