What side effects are associated with this type of intervention?

Common treatments for Autism, particularly those with properties similar to Cannabidiol (CBD), can have various side effects. Omega-3 fatty acids, while generally well-tolerated, may cause gastrointestinal issues like nausea and diarrhea. CBD-based treatments have shown potential in reducing severe behavioral problems but can lead to changes in appetite and, in rare instances, serious psychotic events. Other cannabinoids may cause dizziness, sedation, confusion, and dissociation.

What prior FDA approvals exist?

The FDA has approved risperidone and aripiprazole for the treatment of irritability associated with autism spectrum disorder (ASD). These medications have antipsychotic properties and are used to manage symptoms such as aggression, self-injury, and severe tantrums. While cannabidiol is being studied for its potential benefits in reducing severe behavioral problems in children with autism, it is not yet FDA-approved for this indication. Cannabidiol has shown promise due to its anti-inflammatory, anxiolytic, and antipsychotic effects, but more research is needed to establish its efficacy and safety for treating autism.

What other types of research exist?

Promising novel alternatives to cannabidiol for autism patients include: 1) Aripiprazole and Risperidone, which are antipsychotics approved for irritability associated with autism; 2) Bumetanide, a diuretic showing potential in reducing core symptoms of autism; 3) Oxytocin, being studied for its effects on social behaviors; 4) Balovaptan, a vasopressin receptor antagonist under investigation for socialization and communication improvements. These alternatives are being explored for their efficacy and safety in managing autism-related symptoms.

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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)

Summary

This trial is testing whether a medicine called cannabidiol (CBD) can help boys aged 7-14 with autism who have severe behavior problems. CBD, which comes from the cannabis plant but doesn't make you feel 'high,' might help by calming brain activity. The goal is to see if this treatment can improve their behavior and quality of life. Cannabidiol (CBD) has been reported to be safe and well-tolerated and has shown potential in managing symptoms of 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.

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.

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Autism Diagnostic Observation Scale- 2 (ADOS-2)

Total Score on Child Behavior Checklist (CBCL)

Total Score on Repetitive Behavior Scale-Revised (RBS-R)

Secondary study objectives

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 study objectives

Magnetic Resonance Spectroscopy

Side effects data

From 2022 Phase 1 & 2 trial • 3 Patients • NCT04238754

67%

Abdominal Pain

33%

Drowsiness

33%

Headache

33%

Nausea

100%

80%

60%

40%

20%

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

2023

Completed Phase 2

~530

Do I qualify?Apply below to find out

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.