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Cannabidivarin (CBDV) vs. Placebo in Children with Autism Spectrum Disorder (ASD)

April 12, 2019 - July 31, 2023

There is a clear unmet need for new medicines to treat irritability in children with ASD that do not have the metabolic and weight adverse event profiles of the currently approved treatments. Cannabidivarin (CBDV), a nonpsychoactive phytocannabinoid with no appreciable tetrahydrocannabinol (THC), has potential therapeutic effects on irritability and disruptive behaviors, repetitive behaviors, sociability, and quality of life, as well as the capacity to reduce inflammation.

What are the goals of the study?

This study aims to examine the efficacy and safety of CBDV, with a primary aim of studying its effect on irritability in children with ASD.

What will happen during the visit or online?

It will take about 16 weeks to complete this study. During this time, we will ask you to come to Albert Einstein College of Medicine 4 times for study visits. (Baseline, Week 4, Week 8, and Week 12). In addition, we will ask you to complete 5 remote visits. Two out of these 5 remote visits will involve assessments performed over the phone, as well as a visit to your local QUEST diagnostic center (at no cost to you, at Screening and Week 2 ) The other 3 remote visits will only involve assessments performed over the phone (Weeks 6, 10, and 14). On-site visits include a physical and neurological exam, measuring vital signs, lab work, and completion of assessments/questionnaires. An ECG will be completed at Baseline and Week 12.

How will this help families?

The goal of this study is to see if CBDV can improve irritability and disruptive behaviors in children with autism spectrum disorder, without the weight gain and metabolic side effects of the FDA approved antipsychotics aripiprazole and risperidone.

Eligibility Criteria

• Male or female between and including ages 5 to 18.
• Diagnosis of Autism Spectrum Disorder (ASD).
• Irritable behaviors.

View the study flyer here.

Contact Information

Bonnie Taylor – botaylor@montefiore.org

Research Study Website
Autism and Obsessive Compulsive Spectrum Program , Psychiatric Research Institute at Montefiore-Einstein (PRIME)

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