Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT05015439

Cannabidiol (CBD) in Adults With ASD

Led by Johns Hopkins University · Updated on 2025-11-10

40

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

C

Charlotte's Web, Inc

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Cannabidiol (CBD) in Adults With ASD

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with autism spectrum disorder based on DSM-5 criteria
  • Have a significant mood disorder, sleep disturbance, or exhibit agitation, aggression, or other challenging behaviors that interfere with function and quality of life as determined by psychiatric interview
Not Eligible

You will not qualify if you...

  • History of alcohol or substance use disorder
  • Positive urine tetrahydrocannabinol (THC) screen at study start
  • Pregnant, breastfeeding, or planning pregnancy during the study or within three months after
  • Unstable liver disease
  • Taking medications that may have significant interactions with CBD, such as clobazam

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

JHBMC

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

E

Elizabeth Wise, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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