NCT04520685

CASCADE: CAnnabidiol Study in Children With Autism Spectrum DisordEr

CAnnabidiol Study in Children With Autism Spectrum DisordEr (CASCADE): A Double-Blind, Placebo-Controlled Study to Investigate Efficacy and Safety of Cannabidiol in Children and Adolescents With Autism

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled study but all study participants will receive the active study medication at some point during the study for at least 12 weeks, and some children with receive CBD for the entire study.

Detailed description

Autism spectrum disorder (ASD) is a relatively common neurodevelopmental disorder manifest by social communication deficits and restricted and repetitive interests. Individuals with ASD often have behavioral issues and psychiatric comorbidities which can be very hard to manage. Currently, there are only two FDA approved medications (aripiprazole and risperidone) for the treatment of irritability in ASD. Both medications have the potential for side effects and are not tolerated in all children with ASD. Anecdotal and some preliminary studies suggest that cannabidiol (CBD), a non-psychoactive cannabinoid in the marijuana plant, may lead to improvements in symptoms of ASD including irritability, aggressive behaviors, and anxiety. In this study the investigators will test whether CBD leads to differences in behaviors commonly associated with ASD. The main behavioral problems investigators will study are irritability and aggressive behavior. This study will also measure changes in other behaviors seen in ASD such as anxiety, social interaction difficulties, repetitive behaviors, attentional problems, hyperactivity, repetitive behaviors, and quality of life. Study investigators will also test whether there are any important side effects of CBD in children and adolescents with ASD.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Oral cannabidiol 100mg/mL	In Arm 1, patients will begin CBD in period 1 and receive placebo in period 2. In Arm 2, patients will begin placebo in period 1 and receive CBD in period 2. In Arm 3, patients will receive CBD for the entire 27 week study duration without washout. Each study period is 12 weeks and dose will be titrated up for 1 week at the beginning of a treatment period and titrated down for 1 week at the end of a treatment period, with a two week placebo washout between periods for Arms 1 and 2. The titration dose will be 5mg/kg/day and the treatment dose will be 10mg/kg/day.
DRUG	Placebo	In Arm 1, patients will begin CBD in period 1 and receive placebo in period 2. In Arm 2, patients will begin placebo in period 1 and receive CBD in period 2. In Arm 3, patients will receive CBD for the entire 27 week study duration without washout. Each study period is 12 weeks and dose will be titrated up for 1 week at the beginning of a treatment period and titrated down for 1 week at the end of a treatment period, with a two week placebo washout between periods for Arms 1 and 2. The titration dose will be 5mg/kg/day and the treatment dose will be 10mg/kg/day.

Timeline

• Start date: 2021-12-15
• Primary completion: 2024-01-31
• Completion: 2024-12-31
• First posted: 2020-08-20
• Last updated: 2024-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study