HOW CAN WE HELP YOU? Call 1-800-TRY-CHOP
Cannabidiol Oral Solution for Children and Teens with ASD
This study is now recruiting.
This study aims to find out if the study drug, GWP42003-P, works to improve symptoms for people with ASD. The study will also look at:
- The safety of the study drug
- What the study drug does to the body, and
- The quality of life of your parent/legal guardian
This is a Phase 2 study, which means that although the study drug has already been tested in other people, it has not been tested in people with ASD. \
\To participate in this study, you (or your child) must: \
- Be 6 to 17 years old
- Have an autism diagnosis
- Have a parent or guardian able to participate as a study partner during the entire study. The study partner will need to attend every visit and answer questionnaires about the child.
- Be able to swallow the liquid solution.
Other eligibility criteria apply.
Who Do I Contact?
If you are interested in participating in the study or want to learn more please contact our study team at wozniaks1 [at] chop.edu or 267-600-5025.
Eligibility & Criteria
IRB #:
21-019364
Official Title:
An exploratory, Phase 2, randomized, double-blind, placebo-controlled trial to investigate the safety and efficacy of cannabidiol oral solution (GWP42003-P; CBD-OS) in children and adolescents with autism spectrum disorder
Study Phase:
Phase II
Eligible Age Range:
6 - 17 Years
Gender:
All
Study Categories:
Visit Criteria
If you are eligible to participate, you would be randomly assigned to one of two groups: a dose of the study drug or a matching placebo (a liquid solution that looks and tastes like the study drug but does not contain any active substance). You will not know which group you are assigned to.
Participation will last approximately 17 weeks (about 4 months) and involve 10 study visits.
- 4 of these visits will take place over the phone
- 3 will take place at CHOP's University City campus
- 3 will take place either by telehealth/home visit or at CHOP's University City campus.
As a participant in research, you will:
- Receive a study drug or placebo; you will not know which;
- Review medical history with the study staff;
- Have blood, urine, and heart monitoring tests;
- Complete a video-recorded social interaction task and speech recording;
- Complete questionnaires and behavioral assessments;
You will not be charged for the research procedures. Participants will be compensated. You do not need to be a patient at CHOP to participate. Please contact the study team if you are interested.
Leader
