Table 3 Study design

From: The treatment of spasticity with Δ9-tetrahydrocannabinol in persons with spinal cord injury

Phases Phase 1 open label Phase 2 open label Phase 3 parallel study randomized double-blind placebo-controlled
Medication Oral THC (Marinol™) Rectal THC (THC-HS) Oral THC versus placebo
Treatment duration 6 weeks 6 weeks 6 weeks
Day of examination 1a 8b 43c 1a 8b 43c 1a 8b 43c
  1. aFirst day of medication with a single dose of 10 mg THC
  2. bIndividual dose adjusted to tolerance of side effects and symptoms of spasticity
  3. cStable individual dose
  4. Wash out period between the phases at least 1 week