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Cannabinoid
CBD for Autism Spectrum Disorder
Phase 2
Waitlist Available
Led By Francisco 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
Must not have
History or current evidence of significantly impaired liver function, defined as 1) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 × upper limit of normal (ULN); 2) ALT or AST > 3 × ULN with concomitant total bilirubin > 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia
Diagnosis of a known genetic disorder (e.g., Prader-Willi Syndrome, Angelman Syndrome, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My liver isn't working well, shown by very high enzyme levels or symptoms like fatigue or pain.
Select...
I have been diagnosed with a genetic disorder.
Select...
I am currently experiencing thoughts of harming myself.
Select...
I have been diagnosed with bipolar disorder, MDD, psychosis, schizophrenia, or PTSD.
Select...
I have been diagnosed with Rett Syndrome, Childhood Disintegrative Disorder, or have significant sensory impairments like deafness or blindness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Global Impression Scale -Improvement (CGI-I)
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,756 Total Patients Enrolled
Francisco Castellanos, MDPrincipal InvestigatorNew York Langone Health
1 Previous Clinical Trials
59 Total Patients Enrolled
Francisco X Castellanos, MDPrincipal InvestigatorNew York Langone Health
1 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: 98% pure CBD
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