Using CBD to treat psychiatric issues in adults with autism
Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder
This study is testing if CBD can help adults with autism feel better by reducing their psychiatric symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05015439 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of cannabidiol (CBD) for treating psychiatric problems in adults with Autism Spectrum Disorder (ASD). It employs a randomized cross-over design involving 40 participants who will receive CBD for six weeks, followed by a two-week washout period, and then six weeks of placebo. Participants will undergo regular evaluations and assessments to monitor anxiety, behavior, daily functioning, cognition, and physical symptoms throughout the study. The goal is to gather data on the potential benefits of CBD in alleviating distressing symptoms associated with ASD.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with Autism Spectrum Disorder who experience significant mood disorders, sleep disturbances, or agitation affecting their quality of life.
Not a fit: Patients with a history of substance use disorder, unstable liver disease, or those taking medications that may interact negatively with CBD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for adults with ASD suffering from anxiety, mood disturbances, and other psychiatric issues.
How similar studies have performed: While there is limited research on CBD specifically for adults with ASD, preliminary studies on CBD for anxiety and mood disorders have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Jhbmc — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Wise, MD — Johns Hopkins University
- Study coordinator: Elizabeth Wise, MD
- Email: ewise11@jhmi.edu
- Phone: 410-550-6207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.