Cannabidiol (CBD) in Adults With ASD
Launched by JOHNS HOPKINS UNIVERSITY · Aug 16, 2021
Trial Information
Current as of April 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether cannabidiol (CBD), a compound found in cannabis, can help improve mental health issues in adults with Autism Spectrum Disorder (ASD). Many adults with ASD experience problems like anxiety, mood swings, sleep difficulties, and agitation, but there are currently no FDA-approved treatments specifically for them. During the 14-week study, participants will take a CBD pill for six weeks, followed by a two-week period without any medication, and then switch to a placebo (an inactive pill) for another six weeks. Throughout the study, participants will have regular check-ins where they will answer questions about their anxiety, behavior, and overall daily functioning.
To be eligible for the trial, participants must be diagnosed with ASD and have significant mood disorders or other troubling behaviors that affect their daily life. Some key exclusions include individuals with a history of substance abuse, pregnant or breastfeeding women, and those with certain medical conditions or medications that could affect the study's results. This trial aims to better understand the safety and effectiveness of CBD for adults with ASD, offering hope for improved treatment options in the future.
Gender
ALL
Eligibility 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
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Elizabeth Wise, MD
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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