Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Maryland
JHBMC
RECRUITING
Baltimore
Contact Information
Primary
Elizabeth Wise, MD
ewise11@jhmi.edu
410-550-6207
Time Frame
Start Date: 2023-04-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
Experimental: Cannabidiol
Participants will receive cannabidiol, starting at 100 mg twice daily, and increased to 200 mg twice daily by week 3. This arm will last six weeks.
Placebo_comparator: Placebo
Participants will receive six weeks of placebo.
Related Therapeutic Areas
Sponsors
Collaborators: Charlotte's Web, Inc
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov