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