← Back to Search

Cannabinoid

CBD for Autism Spectrum Disorder

Phase 2
Waitlist Available
Led By Francisco X Castellanos, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female pediatric outpatients aged between and including 7 to 17.9 years old
Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights

Study Summary

This trial is testing cannabidiol (CBD) to see if it's an effective treatment for symptoms associated with autism spectrum disorder (ASD), in children and adolescents. They are using a 98% pure CBD oral solution, given at a dose of 9 mg/kg/day. They will be testing up to 15 additional participants who also have a diagnosis of attention-deficit/hyperactivity disorder (ADHD).

Who is the study for?
This trial is for children and teens aged 7-17 with Autism Spectrum Disorder (ASD) and an IQ of at least 80. They must have a diagnosis confirmed by specific criteria, including ADHD, be able to speak fluently, and have normal physical exam results. Participants cannot join if they've used CBD or certain medications recently, have a history of drug abuse or severe psychiatric disorders, are pregnant or not using contraception, or have significant liver impairment.Check my eligibility
What is being tested?
The study tests the effects of 98% pure cannabidiol (CBD) on ASD symptoms over six weeks. Initially testing various doses through cohorts, it now focuses exclusively on a dose of 9 mg/kg/day in participants also diagnosed with ADHD. The aim is to find optimal dosing and measure changes in irritability and anxiety among other ASD-related difficulties.See study design
What are the potential side effects?
While CBD has been noted for having a benign side effect profile in children and adolescents with ASD, potential adverse effects may include drowsiness, changes in appetite or mood swings. However, the exact side effects will be closely monitored throughout this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 7 and 17 years old.
Select...
My autism diagnosis was confirmed by ADOS-2 and DSM-5.
Select...
My ADHD diagnosis was confirmed by a clinician using specific assessments.
Select...
My recent physical and lab tests are normal for my age.
Select...
I am between 7 and 17 years old.
Select...
My autism diagnosis was confirmed by ADOS-2 and DSM-5.
Select...
My ADHD diagnosis was confirmed by a clinician using specific assessments.
Select...
My physical and lab tests are normal for my age.
Select...
I am between 7 and 17 years old.
Select...
My autism diagnosis was confirmed by ADOS-2 and DSM-5.
Select...
My ADHD diagnosis was confirmed by a clinician using specific assessments.
Select...
My recent physical exam and lab tests are normal for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Global Impression Scale -Improvement (CGI-I)
Secondary outcome measures
16. Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior (SWAN)
Aberrant Behavior Checklist (ABC) - Irritability and Social Withdrawal Subscales
Anxiety Scale for Children - Autism Spectrum Disorder (ASC-ASD-C) - Child Versions
+13 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 98% pure CBDExperimental Treatment1 Intervention
98% pure CBD. The CBD will be 100mg/mL oral solution provided by Greenwich Biosciences, Inc.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,480 Total Patients Enrolled
Francisco X Castellanos, MDPrincipal InvestigatorNew York Langone Health
1 Previous Clinical Trials
42 Total Patients Enrolled
Francisco Castellanos, MDPrincipal InvestigatorNew York Langone Health
1 Previous Clinical Trials
79 Total Patients Enrolled

Media Library

Autism Spectrum Disorder Research Study Groups: 98% pure CBD

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to take part in this research?

"Up to 30 young patients that have been diagnosed with autism spectrum disorder and are between the ages of seven and seventeen may be admitted into this study. There are a few key requirements that each candidate must meet, these include: having a SRS-2 Total T-score of 66+, being rated with a CGI-S score of 4 or higher, normal physical exam and laboratory results for their age, an IQ of at least 80, being male or female pediatric outpatients aged 7 to 17.9 years old, confirmation of ADHD diagnosis via K-SADS-COMP review and DSM-5 Criteria by clinician, confirmation"

Answered by AI

Can people aged 50 years or more participate in this research project?

"According to the eligibility requirements for this study, 7 is the youngest a patient can be while 17 is the oldest."

Answered by AI

To what extent has the FDA approved CBD for therapeutic use?

"98% CBD has been found to be safe in Phase 2 trials, but there is no data yet supporting its efficacy."

Answered by AI

How many individuals are participating in this research project?

"Yes, as updated on clinicaltrials.gov, this research trial is actively recruiting patients. The first posting was on March 12th, 2019 and the most recent update was July 29th, 2022. So far, 30 individuals have been recruited from 1 site."

Answered by AI

Is there still room for more people in this experiment?

"That is accurate. Based on the information found on clinicaltrials.gov, this study is still looking for volunteers. The listing was created on March 12th, 2019 and updated as recently as July 29th, 2022. They are specifically searching for 30 individuals at a single location."

Answered by AI

What do we know about the effects of CBD that is almost entirely pure?

"83 clinical trials involving 98% CBD are currently underway with 18 of those in Phase 3. While a majority of these studies take place in Ribeirao Preto, Sao Paulo, there are 311 total locations running trials for this concentration of CBD."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
North Carolina
New York
Other
How old are they?
18 - 65
< 18
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

my son is currently in an out of state treatment facility that really has not proven any real improvement. He is currently in the temp custody of the state due to the school pressing charges because of violence at school (and home) he has been on atleast 20 different types of medications,none have had any real long lasting results. I have been told that when he is 18 he will likely be incarcerated if he cannot get his aggression under control but all anyone wants to try is behavior modification. I would like to try different medications for him but cannot get a doctor to agree, perhaps this would be the answer he needs. He is a bright boy, loving and kind. However, he can flip a switch very quickly. He cannot seem to contain his frustration and will lash out with physical harm and yelling. He will bang his head against things as well. He has tried to open car doors. I am desperate for help and would like to see if he qualifies for this trial. Thank you.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

when would the trial start? Would he be able to stay at the hospital?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. NYU Langone Health: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Cannabidiol for ASD Open Trial
2019. "Cannabidiol for ASD Open Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03900923.
All > Asd > Autism
~5 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top