Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder
Johns Hopkins University
Summary
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.
Description
The investigator's study will be a randomized cross-over design, in which all 40 participants receive six weeks of CBD and six weeks of placebo with a 2-week washout in between. Participants will be seen at in-person visits at Baseline and at the end of Weeks 2, 4, and 6 of each arm of the study for clinical evaluation and primary data collection. Two additional telephone visits will be held with participants during Weeks 1 and 3 of each arm to collect data related to safety and drug tolerability. Currently in the clinic, as part of routine care on a semi-annual basis, the investigators admin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 * individua…
Interventions
- DrugCannabidiol
The study intervention will be supplied as a softgel capsule containing cannabidiol.
- DrugPlacebo
The study intervention will be supplied as a softgel capsule containing inert filler.
Location
- JHBMCBaltimore, Maryland