Cannabidivarin for Autism Spectrum Disorder

Phase 2

Recruiting

Led By Eric Hollander, MD

Research Sponsored by Montefiore Medical Center

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 ages 5 to 18 with a diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria (or ADI-R under special circumstances)

Be younger than 65 years old

Must not have

Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment

Diagnosis of a known genetic disorder (ie. Prader-Willi Syndrome, Angelman Syndrome etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in vineland-3 from baseline to week 12 (change over 12 weeks)

Summary

This trial is testing whether a cannabis-based drug called cannabidivarin (CBDV) is effective and safe in treating children with autism spectrum disorder (ASD).

Who is the study for?

This trial is for children aged 5-18 with Autism Spectrum Disorder, confirmed by specific diagnostic criteria. They must have stable treatments and a caregiver to consent and assess their behavior. Excluded are those with recent drug use, certain medical conditions, medication changes within the last month, or known allergies to sesame oil.

What is being tested?

The study tests Cannabidivarin (CBDV) against a placebo in children with ASD to evaluate its effectiveness and safety. Participants will be randomly assigned to receive either CBDV or an inactive substance that looks the same as CBDV.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of CBDV may include drowsiness, gastrointestinal issues like diarrhea or appetite changes, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 to 18 years old and have been diagnosed with Autism Spectrum Disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been on long-term treatment with CBD or similar.

Select...

I have been diagnosed with a genetic disorder.

Select...

My primary mental health condition is not ASD, but includes conditions like bipolar disorder or PTSD.

Select...

I have Rett Syndrome, Childhood Disintegrative Disorder, or a severe sensory impairment like deafness or blindness.

Select...

I am pregnant or can become pregnant and am not using birth control.

Select...

My kidney, pancreas, or blood is not functioning properly based on specific lab tests.

Select...

I have an abnormal heart test result or a significant drop in blood pressure when standing.

Select...

My liver tests are more than twice the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in vineland-3 from baseline to week 12 (change over 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in vineland-3 from baseline to week 12 (change over 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in vineland-3 from baseline to week 12 (change over 12 weeks) for reporting.