Tests cannabidiol for anxiety and mood problems in adults with autism
Compares cannabidiol pills with inactive placebo pills in adults with autism.
Plain-language title generated from the registry record
Registry title: Cannabidiol (CBD) in Adults With ASD
Key facts
- Where
- Baltimore, United StatesSee the site
- Phase
- Phase 1
Where in United States
- JHBMCBaltimore, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johns Hopkins University
- Trial code
- NCT05015439
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder
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.
Inclusion: 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.
Exclusion: individuals taking medications where CBD interaction might significantly alter drug levels, such as clobazam; history of alcohol or substance use disorder; individuals with unstable liver disease; 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.