Cannabidiol (CBD) in Adults With ASD

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Canopy Growth Corporation
• Treatments: Cannabidiol; Epidiolex

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