Table 4 Procedure
From: The treatment of spasticity with Δ9-tetrahydrocannabinol in persons with spinal cord injury
Investigations | ||
|---|---|---|
Baseline without medication | Day 0 and Day 43 | Physical and neurological examination including MAS Laboratory tests: blood picture, CRP, GOT, GPT, γ-GT, urine test, urine drug test Cystomanometry ECG Stress test (arm crank test) Pulmonary function test Neuropsychological tests: Continious Performance Test (CPT), Deux Barrages Test (DB) Hamilton Depression Scale (HDRS) Functional Independence Measure (FIM) Self-ratings: spasticity, pain, mood, concentration |
Phase 1 oral THC | Day 1 | Baseline MAS Administration of 10 mg oral THC 1 h after application MAS 2 h after application MAS Followed by CPT und DB 4 h after application MAS 5 h after application MAS 8 h after application MAS 10 h after application MAS Self-ratings: spasticity, pain, mood, concentration |
Day 8 | Two hours after individual morning medication Physical and neurological examination including MAS Laboratory tests: blood picture, CRP, GOT, GPT, γ-GT, urine test HDRS CPT and DB Self-ratings | |
Day 43 | Two hours after application of oral THC same procedure as in baseline day 0 | |
Phase 2 rectal THC-HS | Day 1 Day 8 Day 43 | Same procedure as in Phase 1 |
Phase 3 oral THC versus placebo | Day 1 Day 8 Day 43 | Same procedure as in Phase 1 |
