NCT05015439RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Aug 2021
- Start date
- 20 Apr 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- Autism
- NCT number
- NCT05015439
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 20 Apr 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- individuals taking medications where CBD interaction might significantly alter drug levels, such as clobazam
Other illness
- history of alcohol or substance use disorder
- individuals with unstable liver disease
Other
- positive urine tetrahydrocannabinol screen at onset of study
- individuals who are pregnant, lactating, or planning pregnancy during or within three months of completing the trial
Who the study is looking for
- ASD based on Diagnostic Statistical Manual 5 (DSM-5) criteria
- a significant mood disorder, sleep disturbance, or exhibit agitation, aggression, or other aberrant behavior that is interfering with function and quality of life, as determined by their psychiatric interview
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| JHBMC Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.