The treatment of spasticity with Delta9-tetrahydrocannabinol in persons with spinal cord injury.
METHODS
Open label study to determine drug dose for a randomized double-blind placebo-controlled parallel study.


OBJECTIVE
To assess the efficacy and side effects of oral Delta(9)-tetrahydrocannabinol (THC) and rectal THC-hemisuccinate (THC-HS) in SCI patients.


METHODS
REHAB Basel, Switzerland.


METHODS
Twenty-five patients with SCI were included in this three-phase study with individual dose adjustment, each consisting of 6 weeks. Twenty-two participants received oral THC open label starting with a single dose of 10 mg (Phase 1, completed by 15 patients). Eight subjects received rectal THC-HS (Phase 2, completed by seven patients). In Phase 3, six patients were treated with oral THC and seven with placebo. Major outcome parameters were the spasticity sum score (SSS) using the Modified Ashworth Scale (MAS) and self-ratings of spasticity.


RESULTS
Mean daily doses were 31 mg with THC and 43 mg with THC-HS. Mean SSS for THC decreased significantly from 16.72 (+/-7.60) at baseline to 8.92 (+/-7.14) on day 43. Similar improvement was seen with THC-HS. We observed a significant improvement of SSS with active drug (P=0.001) in the seven subjects who received oral THC in Phase 1 and placebo in Phase 3. Major reasons for drop out were increase of pain and psychological side effects.


CONCLUSIONS
THC is an effective and safe drug in the treatment of spasticity. At least 15-20 mg per day were needed to achieve a therapeutic effect.
Hagenbach
U
U
REHAB Basel, Centre for Spinal Cord Injury and Severe Head Injury, Basel, Switzerland.
Luz
S
S
Ghafoor
N
N
Berger
J M
JM
Grotenhermen
F
F
Brenneisen
R
R
Mäder
M
M
D000284:Administration, Oral; D000285:Administration, Rectal; D000328:Adult; D000339:Affect; D000368:Aged; D001288:Attention; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D013759:Dronabinol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005080:Exercise Test; D005260:Female; D006801:Humans; D008168:Lung / Q000503:physiopathology; D008297:Male; D008365:Manometry; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology / Q000523:psychology; D009483:Neuropsychological Tests; D010146:Pain / Q000503:physiopathology; D013119:Spinal Cord Injuries / Q000150:complications* / Q000503:physiopathology / Q000523:psychology; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000503:physiopathology
D013759:Dronabinol