A novel water-soluble nanoparticle THC/CBD oro-buccal spray showed acceptable bioavailability, was generally safe and tolerable in 25 advanced cancer patients with uncontrolled pain, with a subgroup achieving 33-40% pain improvement.
Oncologists, palliative care specialists, pharmaceutical researchers, and patients with cancer pain.
Bone metastases subgroup showed 33-40% pain improvement
What the researchers found
The water-soluble formulation produced dose-dependent plasma cannabinoid levels, with higher systemic exposure for THC than CBD. A subgroup with breast and prostate cancers with bone metastases showed the highest mean pain score improvement (40% unadjusted, 33% adjusted for rescue medication). Most reported adverse events were mild to moderate drowsiness (44%) and nausea/vomiting (72%).
Why it matters
Water-soluble nanoparticle formulations could overcome the poor and variable bioavailability of oral cannabinoids, potentially making cannabis-based pain treatments more reliable and effective.
The numbers in context
25 patients in Stage II; AUC from 2.5 mg THC: 1.71 ng·mL·h; AUC from 2.5 mg CBD: 0.65 ng·mL·h. Bone metastases subgroup: 40% pain improvement (33% adjusted). Drowsiness: 44% mild, 6% moderate. Nausea: 72%.
How the study worked
Non-blinded single-arm two-stage pilot study. Stage I: single escalating dose in 5 patients (2.5 mg each THC and CBD, then 3x dose). Stage II: up-titrated dose in 25 patients with advanced cancers and intractable pain despite opioid therapy.
What this study cannot tell us
Pilot study with no control group or blinding. Very small sample. High rate of nausea (though this may be from underlying cancer). Pain improvement data from a subgroup only. Short-term assessment.
How to read the evidence
Open-label pilot study without control group. Preliminary safety and efficacy data only.
When this study was published
Published in 2022.
The bigger picture
For cancer patients whose pain is not controlled by opioids, novel cannabinoid formulations represent an emerging option. The nanoparticle technology could make dosing more predictable than traditional oral cannabis products.
Questions still open
- Would a controlled trial confirm the pain relief seen in the bone metastases subgroup? Can the nanoparticle technology be optimized to increase CBD bioavailability? How does this formulation compare to existing cannabinoid products?
Common questions
What is a nanoparticle cannabis spray?
Did it help with cancer pain?
Read the original research
Pilot clinical and pharmacokinetic study of Δ9-Tetrahydrocannabinol (THC)/Cannabidiol (CBD) nanoparticle oro-buccal spray in patients with advanced cancer experiencing uncontrolled pain.
PloS one, 17(10), e0270543
Citation
Clarke, Stephen; Butcher, Belinda E; McLachlan, Andrew J; Henson, Jeremy D; Rutolo, David; Hall, Sean; Vitetta, Luis. (2022). Pilot clinical and pharmacokinetic study of Δ9-Tetrahydrocannabinol (THC)/Cannabidiol (CBD) nanoparticle oro-buccal spray in patients with advanced cancer experiencing uncontrolled pain.. PloS one, 17(10), e0270543. https://doi.org/10.1371/journal.pone.0270543
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