Actively Recruiting
Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
Led by Montefiore Medical Center · Updated on 2025-10-22
100
Participants Needed
2
Research Sites
407 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
CONDITIONS
Official Title
Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female children aged 5 to 18 years
- Diagnosis of Autism Spectrum Disorder confirmed by ADOS-2 and DSM-5 criteria or ADI-R under special circumstances
- Aberrant Behavior Checklist-Irritability Subscale score of 18 or greater at screening
- Social Responsiveness Scale score of 66T or higher at screening
- Clinical Global Impression Scale-Severity score of 4 or higher at screening
- Stable pharmacologic, educational, behavioral, and/or dietary interventions for 4 weeks prior to randomization and during study
- Physical exam and lab results within normal range for individuals with ASD
- Parent, caregiver, or guardian able to consent and complete assessments; child assent obtained if 7 years or older with capacity
You will not qualify if you...
- Use of any investigational agent within 30 days prior to randomization
- Prior chronic treatment with CBD, CBDV, or endocannabinoid treatments
- Positive urine test for THC or other drugs of abuse at screening or baseline
- Drug abuse including marijuana/cannabis use in past 3 months
- Diagnosis of known genetic disorders such as Prader-Willi Syndrome or Angelman Syndrome
- Primary psychiatric diagnosis other than ASD (e.g., bipolar disorder, psychosis, schizophrenia, PTSD, major depressive disorder)
- Medical condition severely impacting study participation or safety
- Diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or significant sensory impairment like deafness or blindness
- Changes in allied health therapies, behavioral or educational interventions within 4 weeks prior to randomization except school holidays
- Changes in medications or doses within 4 weeks prior to randomization
- Renal, pancreatic, hematologic dysfunction outside specified lab limits
- Liver dysfunction with AST or ALT levels greater than twice upper normal limit
- ECG abnormalities or clinically significant blood pressure drops at screening
- Female participants who are pregnant or unwilling to avoid pregnancy during study
- Known allergy to sesame oil
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
New York University (NYU) Langone
New York, New York, United States, 10016
Completed
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
C
Casara Ferretti, MS, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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