A double‐blind, randomized, placebo‐controlled, parallel group study of THC/CBD spray in peripheral neuropathic pain treatment
Abstract
Background: Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ 9‐tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15‐week randomized, double‐blind, placebo‐controlled parallel group study. Methods: In total, 303 patients with PNP associated with allodynia were screened; 128 were randomized to THC/CBD spray and 118 to placebo, in addition to their current analgesic therapy. The co‐primary efficacy endpoints were the 30% responder rate in PNP 0–10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated. Results: At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention‐to‐treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05–3.70]. There was also a reduction in mean PNP 0–10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0–10 NRS score (p = 0.0072) and S ubject G lobal I mpression of C hange (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment. Conclusions: These findings demonstrate that, in a meaningful proportion of otherwise treatment‐resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified.
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Although the five studies found improvements in nausea with cannabis use, other studies found nausea to be an adverse event associated with cannabis use among some participants.
“Although these five studies found improvements in nausea with cannabis use, other studies found nausea to be an adverse event associated with cannabis use among some participants.”
From Clinical Practice Guidelines for Cannabis and Cannabinoid-Based Medicines in the Management of Chronic Pain and Co-Occurring Conditions (2024) · cites this paper as [57]
The oromucosal spray Sativex, containing an equal mixture of THC and CBD, demonstrated a significant analgesic effect in neuropathic pain.
“The oromucosal spray Sativex that contains an equal mixture of THC and CBD (approved in Canada and European countries) demonstrated a significant analgesic effect in neuropathic pain (Serpell et al, 2014).”
From The endogenous cannabinoid system: a budding source of targets for treating inflammatory and neuropathic pain (2018) · cites this paper as Serpell et al, 2014
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- Authors
- Serpell, M., Ratcliffe, S., Hovorka, J., Schofield, M., Taylor, L., Lauder, H., & Ehler, E.
- Affiliations
- Gartnavel General Hospital (GB)
- MAC Clinical Research (United Kingdom) (GB)
- General University Hospital in Prague (CZ)
- West Suffolk Hospital (GB)
- GW Pharmaceuticals (United Kingdom) (GB)
- Nemocnice Pardubického Kraje (CZ)
- Corresponding author
- Serpell, M.
- ORCID
- Venue
- European Journal of Pain
- Publisher
- Wiley
- Published
- 2014-01-13
- Volume
- 18
- Issue
- 7
- Pages
- 999-1012
- ISSN
- 1090-3801 (ISSN-L)
- 1532-2149
- OpenAlex
- W2112026566
- Cited by
- 197
- References
- 41
- Citations by year
- 2026: 8 · 2025: 14 · 2024: 15 · 2023: 12 · 2022: 32 · 2021: 24 · 2020: 25 · 2019: 15 · 2018: 20 · 2017: 10 · 2016: 10 · 2015: 9 · 2014: 3
- FWCI
- 7.78
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Pain (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
- Keywords
- peripheral neuropathic pain, allodynia, oromucosal spray, cannabinoids, tetrahydrocannabinol, cannabidiol, analgesia, sleep quality, treatment-resistant pain, tolerability
- MeSH terms
- Adult, Aged, Aged, 80 and over, Analgesics, Cannabidiol, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Neuralgia, Pain Measurement, Peripheral Nervous System Diseases, Dronabinol, Treatment Outcome
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