Home › Autism Spectrum Disorder › NCT05015439

Cannabidiol (CBD) in Adults With ASD

Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* 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 Criteria:

* history of alcohol or substance use disorder
* 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
* individuals with unstable liver disease
* individuals taking medications where CBD interaction might significantly alter drug levels, such as clobazam

About the study

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.

What is being tested

• Cannabidiol (drug)
• Placebo (drug)

Sponsor: Johns Hopkins University · Participants: 40 · Started: Apr 20, 2023

Contact the study team

• Elizabeth Wise, MD · Phone: 410-550-6207

Official record on ClinicalTrials.gov — NCT05015439

Locations in the U.S.

Conditions

• Autism Spectrum Disorder

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.