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Nabilone as an adjunctive to gabapentin for multiple sclerosis-induced neuropathic pain: a randomized controlled trial.

Abstract

BACKGROUND

Neuropathic pain (NPP) is a chronic syndrome suffered by patients with multiple sclerosis (MS), for which there is no cure. Underlying cellular mechanisms involved in its pathogenesis are multifaceted, presenting significant challenges in its management.

METHODS

A randomized, double-blind, placebo-controlled study involving 15 relapsing-remitting MS patients with MS-induced NPP was conducted to evaluate nabilone combined with gabapentin (GBP). Eligible patients stabilized on GBP (≥1,800 mg/day) with inadequate pain relief were recruited. Nabilone or placebo was titrated over 4 weeks (0.5 mg/week increase) followed by 5-week maintenance of 1 mg oral nabilone (placebo) twice daily. Primary outcomes included two daily patient-reported measures using a 100-mm visual analog scale (VAS), pain intensity (VASpain), and impact of pain on daily activities (VASimpact). Hierarchical regression modeling was conducted on each outcome to determine if within-person pain trajectory differed across study groups, during 63-day follow-up.

RESULTS

After adjustment for key patient-level covariates (e.g., age, sex, Expanded Disability Status Scale, duration of MS, baseline pain), a significant group × time(2) interaction term was reported for both the VASpain (P < 0.01) and VASimpact score (P < 0.01), demonstrating the adjusted rate of decrease for both outcomes was statistically greater in nabilone vs placebo study group. No significant difference in attrition rates was noted between treatments. Nabilone was well tolerated, with dizziness/drowsiness most frequently reported.

CONCLUSION

Nabilone as an adjunctive to GBP is an effective, well-tolerated combination for MS-induced NPP. The results of this study identify a novel therapeutic combination for use in this population of patients predisposed to tolerability issues that may otherwise prevent effective pain management.

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  • Authors+Show Affiliations

    ,

    Faculty of Pharmacy, University of Manitoba, Winnipeg, Manitoba, Canada.

    , , , , , ,

    Source

    Pain medicine (Malden, Mass.) 16:1 2015 Jan pg 149-59

    MeSH

    Adult
    Amines
    Analgesics
    Cyclohexanecarboxylic Acids
    Double-Blind Method
    Dronabinol
    Female
    Gabapentin
    Humans
    Male
    Middle Aged
    Multiple Sclerosis, Relapsing-Remitting
    Neuralgia
    Pain Measurement
    gamma-Aminobutyric Acid

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    25288189

    Citation

    Turcotte, Dana, et al. "Nabilone as an Adjunctive to Gabapentin for Multiple Sclerosis-induced Neuropathic Pain: a Randomized Controlled Trial." Pain Medicine (Malden, Mass.), vol. 16, no. 1, 2015, pp. 149-59.
    Turcotte D, Doupe M, Torabi M, et al. Nabilone as an adjunctive to gabapentin for multiple sclerosis-induced neuropathic pain: a randomized controlled trial. Pain Med. 2015;16(1):149-59.
    Turcotte, D., Doupe, M., Torabi, M., Gomori, A., Ethans, K., Esfahani, F., ... Namaka, M. (2015). Nabilone as an adjunctive to gabapentin for multiple sclerosis-induced neuropathic pain: a randomized controlled trial. Pain Medicine (Malden, Mass.), 16(1), pp. 149-59. doi:10.1111/pme.12569.
    Turcotte D, et al. Nabilone as an Adjunctive to Gabapentin for Multiple Sclerosis-induced Neuropathic Pain: a Randomized Controlled Trial. Pain Med. 2015;16(1):149-59. PubMed PMID: 25288189.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Nabilone as an adjunctive to gabapentin for multiple sclerosis-induced neuropathic pain: a randomized controlled trial. AU - Turcotte,Dana, AU - Doupe,Malcolm, AU - Torabi,Mahmoud, AU - Gomori,Andrew, AU - Ethans,Karen, AU - Esfahani,Farid, AU - Galloway,Katie, AU - Namaka,Mike, Y1 - 2014/10/07/ PY - 2014/10/8/entrez PY - 2014/10/8/pubmed PY - 2016/3/25/medline KW - Chronic Pain KW - Controlled Trial KW - Gabapentin KW - Multiple Sclerosis KW - Neuropathic Pain KW - Pain Management SP - 149 EP - 59 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 16 IS - 1 N2 - BACKGROUND: Neuropathic pain (NPP) is a chronic syndrome suffered by patients with multiple sclerosis (MS), for which there is no cure. Underlying cellular mechanisms involved in its pathogenesis are multifaceted, presenting significant challenges in its management. METHODS: A randomized, double-blind, placebo-controlled study involving 15 relapsing-remitting MS patients with MS-induced NPP was conducted to evaluate nabilone combined with gabapentin (GBP). Eligible patients stabilized on GBP (≥1,800 mg/day) with inadequate pain relief were recruited. Nabilone or placebo was titrated over 4 weeks (0.5 mg/week increase) followed by 5-week maintenance of 1 mg oral nabilone (placebo) twice daily. Primary outcomes included two daily patient-reported measures using a 100-mm visual analog scale (VAS), pain intensity (VASpain), and impact of pain on daily activities (VASimpact). Hierarchical regression modeling was conducted on each outcome to determine if within-person pain trajectory differed across study groups, during 63-day follow-up. RESULTS: After adjustment for key patient-level covariates (e.g., age, sex, Expanded Disability Status Scale, duration of MS, baseline pain), a significant group × time(2) interaction term was reported for both the VASpain (P < 0.01) and VASimpact score (P < 0.01), demonstrating the adjusted rate of decrease for both outcomes was statistically greater in nabilone vs placebo study group. No significant difference in attrition rates was noted between treatments. Nabilone was well tolerated, with dizziness/drowsiness most frequently reported. CONCLUSION: Nabilone as an adjunctive to GBP is an effective, well-tolerated combination for MS-induced NPP. The results of this study identify a novel therapeutic combination for use in this population of patients predisposed to tolerability issues that may otherwise prevent effective pain management. SN - 1526-4637 UR - https://www.unboundmedicine.com/medline/citation/25288189/Nabilone_as_an_adjunctive_to_gabapentin_for_multiple_sclerosis_induced_neuropathic_pain:_a_randomized_controlled_trial_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/pme.12569 DB - PRIME DP - Unbound Medicine ER -