Cannabidiol (CBD) in Adults With ASD

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.

Conditions

Autism Spectrum Disorder

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Study Overview

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Study Details

Study overview

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.

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

Cannabidiol (CBD) in Adults With ASD

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Baltimore

JHBMC, Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Johns Hopkins University,

Elizabeth Wise, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-12