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Cannabidiol (CBD) in Adults With ASD

RecruitingPhase 1Ages 18 Years - anyAllJohns Hopkins University
NCT05015439 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Cannabidiol
  • Placebo
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Where

1 site
JHBMC
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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