CASCADE: CAnnabidiol Study in Children With Autism Spectrum DisordEr

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

January 31, 2024

Study Completion Date

December 31, 2024

Conditions
Autism Spectrum Disorder
Interventions
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.

Trial Locations (1)

80045

Children's Hospital Colorado, Aurora

All Listed Sponsors
lead

University of Colorado, Denver

OTHER