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Cannabidiol for Autism

Phase 2 & 3
Waitlist Available
Led By Doris Trauner, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Awards & highlights

Study Summary

This trial is testing whether cannabidiol can help reduce severe behavioral problems in people with autism.

Who is the study for?
This trial is for boys aged 7-14 with autism who exhibit severe behaviors like aggression, self-harm, and hyperactivity almost daily. They must have a confirmed diagnosis of autism based on ADOS testing and significant functional impairment due to these behaviors.Check my eligibility
What is being tested?
The study tests if cannabidiol (Epidiolex) can reduce severe behavioral problems in children with autism compared to a placebo. It aims to see if the drug helps with aggressive behavior, self-harm, repetitive actions, or extreme hyperactivity.See study design
What are the potential side effects?
While not specified here, cannabidiol may cause drowsiness, changes in appetite or mood, diarrhea, fatigue among other potential side effects. Specific reactions will be monitored throughout the trial.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Autism Diagnostic Observation Scale- 2 (ADOS-2)
Total Score on Child Behavior Checklist (CBCL)
Total Score on Repetitive Behavior Scale-Revised (RBS-R)
Secondary outcome measures
Total Score on Aberrant Behavior Checklist (ABC)
Total Score on Children's Sleep Habits Questionnaire (CSHQ)
Total Score on Expressive One Word Picture Vocabulary test, Fourth Edition (EOWPVT-4)
+3 more
Other outcome measures
Magnetic Resonance Spectroscopy

Side effects data

From 2022 Phase 1 & 2 trial • 3 Patients • NCT04238754
Abdominal Pain
Study treatment Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: cannabidiolExperimental Treatment1 Intervention
cannabidiol arm
Group II: placeboPlacebo Group1 Intervention
placebo arm
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism, particularly those similar to Cannabidiol (CBD), often work through anti-inflammatory, anxiolytic, and antipsychotic mechanisms. CBD's anti-inflammatory properties may help reduce neuroinflammation, which is thought to play a role in Autism. Its anxiolytic effects can alleviate anxiety, a common comorbidity in Autism, thereby improving overall behavior and social interactions. The antipsychotic properties of CBD can help manage severe behavioral issues such as aggression and self-harm. These mechanisms are crucial for Autism patients as they address core symptoms and improve quality of life, making it easier for them to engage in daily activities and social interactions.
Brief Report: Cannabidiol-Rich Cannabis in Children with Autism Spectrum Disorder and Severe Behavioral Problems-A Retrospective Feasibility Study.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,132 Previous Clinical Trials
1,551,163 Total Patients Enrolled
Wholistic Research and Education FoundationUNKNOWN
Doris Trauner, MD3.511 ReviewsPrincipal Investigator - University of California, San Diego
University of California, San Diego
1Patient Review
They were quite rude to my little ones and myself. I would not recommend this dentist to anyone.

Media Library

Epidiolex (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04517799 — Phase 2 & 3
Autism Research Study Groups: cannabidiol, placebo
Autism Clinical Trial 2023: Epidiolex Highlights & Side Effects. Trial Name: NCT04517799 — Phase 2 & 3
Epidiolex (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04517799 — Phase 2 & 3
~8 spots leftby Jun 2025