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The treatment of spasticity with Delta9-tetrahydrocannabinol in persons with spinal cord injury.
Spinal Cord. 2007 Aug; 45(8):551-62.SC

Abstract

STUDY DESIGN

Open label study to determine drug dose for a randomized double-blind placebo-controlled parallel study.

OBJECTIVES

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

SETTING

REHAB Basel, Switzerland.

METHOD

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.

CONCLUSION

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.

Authors+Show Affiliations

REHAB Basel, Centre for Spinal Cord Injury and Severe Head Injury, Basel, Switzerland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

17043680

Citation

Hagenbach, U, et al. "The Treatment of Spasticity With Delta9-tetrahydrocannabinol in Persons With Spinal Cord Injury." Spinal Cord, vol. 45, no. 8, 2007, pp. 551-62.
Hagenbach U, Luz S, Ghafoor N, et al. The treatment of spasticity with Delta9-tetrahydrocannabinol in persons with spinal cord injury. Spinal Cord. 2007;45(8):551-62.
Hagenbach, U., Luz, S., Ghafoor, N., Berger, J. M., Grotenhermen, F., Brenneisen, R., & Mäder, M. (2007). The treatment of spasticity with Delta9-tetrahydrocannabinol in persons with spinal cord injury. Spinal Cord, 45(8), 551-62.
Hagenbach U, et al. The Treatment of Spasticity With Delta9-tetrahydrocannabinol in Persons With Spinal Cord Injury. Spinal Cord. 2007;45(8):551-62. PubMed PMID: 17043680.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The treatment of spasticity with Delta9-tetrahydrocannabinol in persons with spinal cord injury. AU - Hagenbach,U, AU - Luz,S, AU - Ghafoor,N, AU - Berger,J M, AU - Grotenhermen,F, AU - Brenneisen,R, AU - Mäder,M, Y1 - 2006/10/17/ PY - 2006/10/18/pubmed PY - 2007/9/21/medline PY - 2006/10/18/entrez SP - 551 EP - 62 JF - Spinal cord JO - Spinal Cord VL - 45 IS - 8 N2 - STUDY DESIGN: Open label study to determine drug dose for a randomized double-blind placebo-controlled parallel study. OBJECTIVES: To assess the efficacy and side effects of oral Delta(9)-tetrahydrocannabinol (THC) and rectal THC-hemisuccinate (THC-HS) in SCI patients. SETTING: REHAB Basel, Switzerland. METHOD: 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. CONCLUSION: 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. SN - 1362-4393 UR - https://www.unboundmedicine.com/medline/citation/17043680/The_treatment_of_spasticity_with_Delta9_tetrahydrocannabinol_in_persons_with_spinal_cord_injury_ L2 - http://dx.doi.org/10.1038/sj.sc.3101982 DB - PRIME DP - Unbound Medicine ER -