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

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 86 (ACTUAL)
Start date: 2021-12-15
Sponsor: University of Colorado, Denver
Design: RANDOMIZED · CROSSOVER · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Research network

Researchers and organizations

Owen Miller

Interventions

What was registered

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.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: Not accepted

Inclusion criteria

Male or female children and adolescents aged 5-17 years, inclusive, at the time of screening.
Judged by the investigator to be in good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results.
Patients must have a previous documented diagnosis of ASD by a medical or psychological professional.
Patients must be assessed by the Investigator as being moderately to severely impacted due to ASD
Patients who are taking psychotropic medication(s) should be on a stable regimen of no more than 2 medications for at least 4 weeks preceding study Screening and must maintain that regimen throughout the study. Psychotropic medications include (but are not limited to) antipsychotics, antidepressants, mood stabilizers, anxiolytics, and ADHD medications.
Patients with a history of seizure disorders must currently be receiving treatment with a stable regimen of one or two AEDs, or must be seizure-free for 1 year if not currently receiving AEDs.
Patients with seizures should be on a stable regimen for the 3 months preceding study enrollment of no more than 2 of the permitted anti-epileptic drugs (AEDs). Patients must remain on a stable AED dose throughout the study.
If patients are receiving non-pharmacological educational, behavioral, and/or dietary interventions or therapies, they must be stable and have been doing so for 2 months prior to screening. Changes with school breaks are expected and do not apply.
Patients must have a BMI of between 12-32 kg/m2 (inclusive).
Females of childbearing potential and must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at all designated visits.
Patients/caregivers agree to abide by all study restrictions and comply with all study procedures.
Parents/caregivers must be able to read and respond to questions and questionnaires in English.
Patients/caregivers must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
Parents/caregiver(s) must provide written consent to assist in study drug administration.
In the Investigator's opinion, patients/caregivers are reliable and willing and able to comply with all protocol requirements and procedures (including scheduled visits and confinement periods).

primary outcomes