The treatment of spasticity with Δ9-tetrahydrocannabinol in persons with spinal cord injury
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.
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A later study reported that 18% of patients with spinal cord injuries reported pain relief following treatment with oral dronabinol (mean 31 mg per day), whereas 23% experienced enhancement of pain, resulting in subsequent withdrawal by several patients.
“A later study reported that 18% of the patients with spinal cord injuries reported pain relief following treatment with oral dronabinol (mean 31 mg per day), whereas 23% experienced enhancement of pain, resulting in subsequent withdrawal by several patients.163”
From Cannabinoids as Pharmacotherapies for Neuropathic Pain: From the Bench to the Bedside (2009) · cites this paper as [163]
Changes in experimental design after initiation of the study complicate interpretation of these latter findings.
“Changes in experimental design after initiation of the study complicate interpretation of these latter findings.163”
From Cannabinoids as Pharmacotherapies for Neuropathic Pain: From the Bench to the Bedside (2009) · cites this paper as [163]
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References 47 · Cited by 70
- Authors
- Hagenbach, U., Luz, S., Ghafoor, N., Berger, J. M., Grotenhermen, F., Brenneisen, R., & Mäder, M.
- Affiliations
- REHAB Basel (CH)
- Nova Institut (DE)
- University of Bern (CH)
- Venue
- Spinal Cord
- Published
- 2006-10-17
- Volume
- 45
- Issue
- 8
- Pages
- 551-562
- ISSN
- 1362-4393 (ISSN-L)
- 1476-5624
- OpenAlex
- W2122385679
- Cited by
- 70
- References
- 47
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 1 · 2023: 3 · 2022: 10 · 2021: 4 · 2020: 9 · 2019: 3 · 2018: 6 · 2017: 1 · 2016: 3 · 2015: 3 · 2014: 2 · 2013: 1 · 2012: 3
- FWCI
- 1.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Spinal Cord (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Neurology › Botulinum Toxin and Related Neurological Disorders
- Health Sciences › Medicine › Pathology and Forensic Medicine › Spinal Cord Injury Research
- Keywords
- spasticity, tetrahydrocannabinol, spinal cord injury, cannabinoids, Modified Ashworth Scale, adverse effects, pain, psychological side effects
- MeSH terms
- Administration, Oral, Administration, Rectal, Adult, Affect, Aged, Attention, Urinary Bladder, Dose-Response Relationship, Drug, Double-Blind Method, Exercise Test, Female, Humans, Lung, Male, Manometry, Middle Aged, Muscle Spasticity, Neuropsychological Tests, Pain, Spinal Cord Injuries, Dronabinol, Treatment Outcome
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