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Cannabidiol (CBD) in Adults With ASD

Johns Hopkins University · with Charlotte's Web, Inc · NCT05015439

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
40
US sites recruiting
1
Study start
April 20, 2023
Record last updated
November 10, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Cannabidiol; Placebo

Conditions: Autism Spectrum Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Elizabeth Wise, MD · 410-550-6207 · ewise11@jhmi.edu
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Cannabidiol (CBD) in Adults With ASD (NCT05015439) | Bored Studies