CBD for Autism

(CASCADE Trial)

Overseen By Rebecca Rochowiak, MA

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must be taking: Psychotropics, AEDs

Must not be taking: Clobazam, Felbamate

Disqualifiers: Pregnancy, THC use, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 27 weeks

86 Participants Needed

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cannabidiol or placebo for 12 to 27 weeks, depending on the group assignment

27 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Oral cannabidiol 100mg/mL
• Placebo

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+