Actively Recruiting
Cannabidiol (CBD) in Adults With ASD
Led by Johns Hopkins University · Updated on 2025-11-10
40
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
C
Charlotte's Web, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
There are no FDA approved treatments for use in adults with autism spectrum disorder (ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is beneficial for those psychiatric problems. This study is to learn more about the effectiveness and safety of CBD in the treatment of psychiatric problems in adults with ASD. The study will last 14 weeks total, during which six weeks participants will receive a pill containing CBD, two weeks where participants will receive no drug/placebo, and six weeks where participants will receive the placebo, an inactive pill. As part of the study, participants will have regular visits and be asked questions about anxiety, challenging behaviors, daily functioning, cognition, and physical symptoms, on standard assessments.
CONDITIONS
Official Title
Cannabidiol (CBD) in Adults With ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with autism spectrum disorder based on DSM-5 criteria
- Have a significant mood disorder, sleep disturbance, or exhibit agitation, aggression, or other challenging behaviors that interfere with function and quality of life as determined by psychiatric interview
You will not qualify if you...
- History of alcohol or substance use disorder
- Positive urine tetrahydrocannabinol (THC) screen at study start
- Pregnant, breastfeeding, or planning pregnancy during the study or within three months after
- Unstable liver disease
- Taking medications that may have significant interactions with CBD, such as clobazam
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
JHBMC
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
E
Elizabeth Wise, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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