CBD for Autism

(CASCADE Trial)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for children and adolescents aged 5-17 with Autism Spectrum Disorder (ASD). They must be on a stable regimen of no more than two psychotropic or anti-epileptic drugs, if applicable, and not planning to change treatments during the study. Participants need a BMI between 12-32 kg/m2 and have been diagnosed by a professional. Females who can bear children must test negative for pregnancy.

Inclusion Criteria

Parents/caregivers need to be able to read and answer questions and forms in English.

If you take medication for mental health, you need to have been on the same medication for at least 4 weeks before the study starts, and you can't change it during the study.

If you are getting non-medication treatments or therapies, they must be stable for at least 2 months before the screening. Changes during school breaks are okay.

Exclusion Criteria

Plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study

You have a suspected or confirmed heart or blood vessel problem.

Adolescent females who are pregnant, nursing, or planning a pregnancy. Females of childbearing potential and male patients with a partner of childbearing potential who are unwilling or unable to use standard acceptable methods of contraception (including abstinence, hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, or intrauterine device) for the duration of the study and for 1 month after the last dose of study medication

Treatment Details

Interventions

• Oral cannabidiol 100mg/mL (Cannabinoid)
• Placebo (Behavioural Intervention)

Trial Overview The CASCADE trial tests oral cannabidiol (CBD) against a placebo in kids with ASD. It's randomized and controlled, meaning some get CBD while others get an inactive substance without knowing which one they receive. All participants will eventually receive CBD for at least 12 weeks during the study.

Participant Groups

Group I: Arm 3: 27 weeks of study drug Experimental Treatment 1 Intervention

Subjects in this group will receive cannabidiol throughout the entire 27 weeks of treatment.

Group II: Arm 3: 15 weeks of placebo then 12 weeks of study drug Experimental Treatment 2 Interventions

Subjects in this group will receive placebo for the first 15 weeks of the study and cannabidiol for the last 12 weeks.

Group III: Arm 1: 12 weeks of study drug then 15 weeks of placebo Experimental Treatment 2 Interventions

Subjects in this group will receive cannabidiol for the first 12 weeks of the study and placebo for the last 15 weeks.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences