A prospective open‐label trial of a CBD/THC cannabis oil in dravet syndrome

PURPOSE

The purpose of this study was to establish a dose guideline for pure CBD therapy for seizure reduction. The mean dose of CBD achieved was 13.3 mg/kg/day of CBD (range 7–16 mg/kg/day). Based on the dose measurements below, this would be approximately 1 full dropper of CBD oil from the 500mg bottle of CBD oil.

Initial research in CBD for childhood seizure reduction was based around CBD/THC combination products with ratios ranging from 20:1 CBD/THC to 50:1 CBD/THC. Recently studies on pure CBD (thc-free cbd oil) are showing similar benefits to the CBD/THC blends that are illegal in the majority of states or require a prescription for Medical Marijuana.

To better understand CBD dosage, consider the following dose strengths from the most common sizes of CBD tincture sold:

  • 250 mg bottle = 30 mL or 30-1 ml servings that equal 8.33mg CBD each 
  • 500 mg bottle = 30 mL or 30-1 ml serving that equal 16.67mg CBD each 
  • 1000 mg bottle = 30 mL or 30-1 ml serving that equal 33.34mg CBD each 

Both Δ9 Tetrahydrocannabidiol (THC) and cannabidiol (CBD) components of cannabis, have been shown to have anticonvulsant effects. Cannabis oils are used to treat seizures in drug‐resistant epilepsy (DRE). Recent trials provide data on dosing, side effects, and efficacy of CBD, yet there is a paucity of information on THC in epilepsy. Primary objective was to establish dosing and tolerability of TIL‐TC150 ‐ a cannabis plant extract produced by Tilray®, containing 100 mg/mL CBD and 2 mg/mL THC‐ in children with Dravet syndrome. Secondary objectives were to assess impact of therapy on seizures, electroencephalogram (EEG) and quality of life.

Methods

Twenty children received add‐on therapy with TIL‐TC150. The dose ranged from 2 to 16 mg/kg/day of CBD and 0.04 to 0.32 mg/kg/day of THC. Patients were monitored for tolerability and adverse events, and secondary objectives.

Results

Nineteen participants completed the 20‐week intervention. Mean dose achieved was 13.3 mg/kg/day of CBD (range 7–16 mg/kg/day) and 0.27 mg/kg/day of THC (range 0.14–0.32 mg/kg/day). Adverse events, common during titration included somnolence, anorexia, and diarrhea. Abnormalities of liver transaminases and platelets were observed with concomitant valproic acid therapy. There was a statistically significant improvement in quality of life, reduction in EEG spike activity, and median motor seizure reduction of 70.6%, with 50% responder rate of 63%.

SOURCE

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