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The treatment of spasticity with Delta9-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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  • Authors+Show Affiliations

    ,

    REHAB Basel, Centre for Spinal Cord Injury and Severe Head Injury, Basel, Switzerland.

    , , , , ,

    Source

    Spinal cord 45:8 2007 Aug pg 551-62

    MeSH

    Administration, Oral
    Administration, Rectal
    Adult
    Affect
    Aged
    Attention
    Dose-Response Relationship, Drug
    Double-Blind Method
    Dronabinol
    Exercise Test
    Female
    Humans
    Lung
    Male
    Manometry
    Middle Aged
    Muscle Spasticity
    Neuropsychological Tests
    Pain
    Spinal Cord Injuries
    Treatment Outcome
    Urinary Bladder

    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), pp. 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 -