Faculty Bibliography

OBJECTIVE:To evaluate cannabidiol (CBD) in pediatric patients with autism spectrum disorder (ASD), fluent verbal language and an estimated full-scale IQ of 80 or above. BACKGROUND:Preliminary evidence suggests CBD may ameliorate challenges associated with ASD. Whether CBD benefits pediatric ASD without accompanying intellectual or language impairment remains unknown. METHODS:, 100 mg/mL) at 3, 6, or 9 mg/kg/day using a Bayesian optimal interval dosing design. The primary endpoint was the CBD dose associated with the highest response rate (i.e., Clinical Global Impression Scale-Improvement [CGI-I] score = 1 or 2) on a target symptom domain designated individually based on informant report, standardized scales, and clinical observation. Secondary endpoints were effect sizes of changes from baseline in measures assessing ASD core and associated symptoms, and global functioning. Adverse events (AEs) were assessed weekly. Plasma CBD levels and clinical labs were obtained at the final visit. RESULTS:= 1.36, 95% CI [0.78-1.93]).Of 222 reported AEs, 27 unique AEs were considered treatment-related. Most AEs (93%) were mild and expected (82%); none was severe. The most frequent related AEs were increased salivation (30%), increased sleep duration (39%), sleepiness/sedation (26%), increased dream activity (35%), and polyuria (22%). Vital signs, physical exams, weight, liver function tests, and complete blood counts were unaffected. CBD plasma levels did not correlate with response. CONCLUSIONS:In this preliminary study, CBD was well tolerated; AEs were mild-moderate. Mean SRS2-T and subscores decreased significantly with large effect sizes, shifting from the severe to the moderate range. CLINICAL TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier NCT03900923.

OBJECTIVE/UNASSIGNED:We used resting-state functional magnetic resonance imaging to identify changes in brain functional connectivity (FC) associated with Organizational Skills Training (OST). METHOD/UNASSIGNED:In an open, waitlist-controlled, randomized clinical trial (NCT04108273), 51 children aged 8-12 years with deficient organizational skills were assigned to immediate tele-health OST treatment (twice weekly, 10 weeks) or waitlist. We obtained Children's Organizational Skills Scale-Parent version (COSS-P) scores and examined FC changes between dorsal anterior cingulate cortex (dACC) and preregistered subcortical anterior ventral striatum (aVS) regions-of-interest. RESULTS/UNASSIGNED: < 0.05). Analyses were then performed with two additional analytic pipelines, neither of which detected any significant effects. CONCLUSION/UNASSIGNED:Although improvements in organizational deficits were associated with increased FC within a circuit linking dACC and the default mode network region of the aVS in one analysis, the direction was the opposite of predicted and results did not replicate. Thus, we highlight the tentativeness of our findings; we have de-identified all the data and made it available for investigators to examine and to combine with other datasets in mega- and meta-analyses. Future studies should also include alternative control conditions and larger samples. CLINICAL TRIAL REGISTRATION/UNASSIGNED:https://clinicaltrials.gov/study/NCT04108273?cond=NCT04108273&rank=1.