NCT03202303 · Montefiore Medical Center
Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
What this study is about
This trial aims to study the effectiveness and safety of cannabidivarin (CBDV) in children with ASD.
View original scientific description
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
Interventions
DRUG
Cannabidivarin
Weight-based dosing of 10 mg/kg/day of CBDV
DRUG
Matched Placebo
Weight-based dosing of 10 mg/kg/day of placebo
Primary outcome measures
Aberrant Behavior Checklist-Irritability (ABC-I) Subscale
Time frame: Change from Baseline to Week 12 (Change over 12 weeks)
Change in aberrant behavior from baseline will be assessed using the irritability subscale of the ABC. The ABC is an informative rating instrument that was empirically derived by principal component analysis to measure behavior in those with developmental disability and autism spectrum disorder (ASD). The ABC-I will be completed by any adult who knows the patient well, such as a parent/caregiver. The ABC-I subscale consists of 15 items that address the presence of aggression, tantrums, and/or self-injury. Scores for each item on the subscale range from 0 (no problem at all) to 3 (problem is severe in degree), yielding an overall possible score for the subscale from 0-45, such that higher scores are indicative of increased severity of irritability. Scores will be summarized by study arm using basic descriptive statistics.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or Female pediatric outpatients aged between and including ages 5 to 18. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria.\*During special circumstances (e.g. COVID-19 pandemic) where the ADOS-2 cannot be performed due to site restrictions (e.g. mandatory use of face masks), eligibility can be confirmed using the Autism Diagnostic Interview, Revised (ADI-R) 2. Aberrant Behavior Checklist (ABC) - Irritability Subscale (ABC-I) score of 18 or greater at screening visit. 3. Social Responsiveness Scale (SRS) score of 66T or higher at screening visit. 4. Clinical Global Impression Scale - Severity (CGI-S) score of 4 or higher at screening. 5. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to randomization and for the duration of the study. 6. Physical exam and laboratory results that are within normal range for individuals with ASD. 7. Presence of a parent/caregiver/guardian that i
Where
- New York, New York
- The Bronx, New York
Collaborators
United States Department of Defense, GW Pharmaceuticals Ltd, Jazz Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2025 · Source of record for eligibility and locations