Cannabidiol (CBD) for Adults with Autism Spectrum Disorder

This study is looking at whether cannabidiol (CBD) can help adults with Autism Spectrum Disorder (ASD) who experience anxiety, mood problems, sleep issues, or agitation. Currently, there are no FDA-approved treatments for these issues in adults with ASD. You might be able to join if you are an adult (18 years or older) with an ASD diagnosis and have significant mood disorders, sleep problems, agitation, or aggression that affects your daily life. The study will measure changes in problematic behaviors using a tool called the Aberrant Behavior Checklist. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is a randomized crossover study where all 40 participants will receive six weeks of cannabidiol (CBD) and six weeks of an inactive pill (placebo), with a two-week break in between.
What's involved
You would have in-person visits at the start and at weeks 2, 4, and 6 of each treatment period. There will also be two phone calls during weeks 1 and 3 of each treatment period. The total study duration is 14 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at six weeks, which is the end of each treatment period. The study lasts 14 weeks in total.

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NCT05015439

Cannabidiol (CBD) in Adults With ASD

Recruiting
PHASE1Ages 18+InterventionalTreatment
Johns Hopkins University
~40 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:CannabidiolPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Aberrant Behaviors as assessed by the Aberrant Behavior Checklist
Measured over baseline and six weeks
Autism Spectrum Disorder

NCT05015439

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • JHBMC

    Baltimore, Marylandno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Elizabeth Wise, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

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Eligibility criteria

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

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
  • Change in Aberrant Behaviors as assessed by the Aberrant Behavior Checklistbaseline and six weeks

    The Aberrant Behavior Checklist (ABC) assesses drug and other treatment effects on individuals with intellectual disability or other developmental disabilities. The ABC consists of a five-factor scale comprising 58 items. Problem behaviors are rated on a categorical scale between 0 (not at all a problem) and 3 (problem is severe in degree). The irritability subscale consists of 15 items, lethargy/social withdrawal consists of 16 items, stereotypic behavior consists of 7 items, hyperactivity/noncompliance consists of 16 items, and inappropriate speech consists of 4 items. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, with higher numbers indicating worse symptoms.