NCT05015439.

Study name	Cannabidiol (CBD) in adults with ASD
Methods	14‐week cross‐over trial of cannabiodiol versus placebo
Participants	Inclusion criteria: male and female aged ≥ 18 years ASD based on DSM‐5 criteria significant mood disorder, sleep disturbance, or exhibit agitation, aggression, or other aberrant behaviour that is interfering with function and QoL, as determined by their psychiatric interview Exclusion criteria: "history of alcohol or substance use disorder; positive urine tetrahydrocannabinol screen at onset of study; positive urine tetrahydrocannabinol screen at onset of study; individuals with unstable liver disease; individuals taking medications where CBD interaction might significantly alter drug levels, such as clobazam". Setting/location: USA Sample size: target sample size is 40
Interventions	Intervention (cannabidiol): 100 mg cannabidiol twice daily in capsule form, increasing to 200 mg twice daily by week 3. This is followed by a 2‐week wash‐out period before starting phase 2 of the cross‐over. Comparator (placebo): equivalent placebo for 6 weeks. This is followed by a 2‐week wash‐out period before starting phase 2 of the cross‐over.
Outcomes	Primary outcomes: change in aberrant behaviours as assessed by the ABC (Aman 1985) adverse effects Secondary outcomes: none reported Timing of outcome assessments: baseline and six weeks (end of phase)
Starting date	Estimated start date: September 2022
Contact information	Contact name: Elizabeth Wise Contact details: ewise11@jhmi.edu
Notes	Source of funding: Johns Hopkins University; Canopy Growth Corporation Conflicts of interest: details not provided