Abstracts

Rationale: Connecticut Children’s medical center was a site for both the Lennox Gastaut and Dravet Epidiolex clinical trials; however, for patients who did not meet the criteria for these trials and for those with other forms of intractable epilepsy, CT medical marijuana program dispensed combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) in pill or oil form with verified amounts. The dosage of CBD provided is much lower than studied in clinical trials based on the belief by the dispensing pharmacists that the presence of THC makes cannabidiol more effective; the rationale behind which was unable to be verified. Therefore, we aim to study the effectiveness of low-dose cannabidiol and also in combination with THC to evaluate for the tolerability of the psychoactive component THC in the pediatric population. Methods: A retrospective analysis of 13 pediatric patients with various forms of refractory epilepsies, who were started on medical marijuana dispensed by the CT medical marijuana program for reduction in seizure frequency was conducted. The primary aims are to identify changes in monthly seizure frequency with this lower dose of cannabidiol and determine the tolerability of psychoactive component THC in the pediatric population. The secondary aim is to determine if there exists a dose dependent response to both of these variables. Results: The mean age was 12 years with 61.5% females (n = 8). 9 of the 13 patients received a combination of CBD and THC in oil or pill form with CBD percentage ranging between 90 - 93%. CBD was started at 0.5 mg/Kg and increased as tolerated with final doses ranging from 1 mg/Kg – 3 mg/Kg. THC doses ranged from 0.1 – 0.3 mg/Kg body weight. Seizure frequency improved in 4 patients (one patient was seizure free for 3 months), worsened in 1 patient and had no change in the rest. Improvement in behavior and mood were noted in 7 patients all of whom had the THC component. Tolerability was also high even at the highest dose of CBD + THC with somnolence reported in just 4 patients initially, three of whom improved after 1 month but caused one patient to quit after just one month.  Conclusions: The combination of low-dose CBD and THC is well tolerated with no reports of liver toxicity and has shown benefits with mood and behavior. There was no statistical significant improvement in monthly seizure frequency. More studies are needed to determine if there exist a dose dependent response to cannabidiols in order to achieve adequate therapeutic responses and improve tolerability. Studies and ethical discussions are also needed to determine the safety and tolerability of psychoactive THC in pediatric population.  Funding: Not applicable