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Cannabinoid
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
Timeline
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks)
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 moreOther outcome measures
Magnetic Resonance Spectroscopy
Side effects data
From 2022 Phase 1 & 2 trial • 3 Patients • NCT0423875467%
Abdominal Pain
33%
Drowsiness
33%
Nausea
33%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Epidiolex
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: cannabidiolExperimental Treatment1 Intervention
cannabidiol arm
Group II: placeboPlacebo Group1 Intervention
placebo arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epidiolex
2020
Completed Phase 2
~380
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You often hurt yourself or others on a regular basis, almost every day.Children who are allergic to any ingredients in the study drug.You have epilepsy.You have serious heart problems, a known brain birth defect, or a history of infection in your brain or spinal cord.You frequently show aggressive or self-injurious behaviors almost every day in different places like home, school, or clinic.Boys between 7 and 14 years old.The seriousness of symptoms will be determined using certain standards.The activities listed above make it difficult for the child to function, according to what the parent and doctor have observed or discussed.You have been diagnosed with autism using ADOS testing.You often do the same actions over and over again, like hand flapping or running in circles, every day for at least 5-10 minutes at a time.The child is extremely active and has trouble sitting still for meals or school work, and is always moving around, jumping off furniture, or climbing onto furniture.Your autism is very severe and comes with significant behavior issues.
Research Study Groups:
This trial has the following groups:- Group 1: cannabidiol
- Group 2: placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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