Pilot study of nanoparticle THC/CBD spray shows safety and early pain relief signals in advanced cancer patients
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.
Quick Facts
What This Study 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%).
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't 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.
Questions This Raises
- ?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?
Trust & Context
- Key Stat:
- Bone metastases subgroup showed 33-40% pain improvement
- Evidence Grade:
- Open-label pilot study without control group. Preliminary safety and efficacy data only.
- Study Age:
- Published in 2022.
- Original Title:
- Pilot clinical and pharmacokinetic study of Δ9-Tetrahydrocannabinol (THC)/Cannabidiol (CBD) nanoparticle oro-buccal spray in patients with advanced cancer experiencing uncontrolled pain.
- Published In:
- PloS one, 17(10), e0270543 (2022)
- Authors:
- Clarke, Stephen, Butcher, Belinda E, McLachlan, Andrew J(3), Henson, Jeremy D, Rutolo, David, Hall, Sean, Vitetta, Luis
- Database ID:
- RTHC-03761
Evidence Hierarchy
A small preliminary study to test whether a larger study is feasible.
What do these levels mean? →Frequently Asked Questions
What is a nanoparticle cannabis spray?
It is a water-soluble formulation that uses nanoparticle technology to improve absorption of THC and CBD when sprayed in the mouth. This aims to overcome the poor and variable absorption of standard oral cannabis products.
Did it help with cancer pain?
A subgroup of patients with breast and prostate cancers with bone metastases showed the most benefit, with 33-40% pain improvement. However, this was a small, uncontrolled pilot study, so larger trials are needed.
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Cite This Study
https://rethinkthc.com/research/RTHC-03761APA
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
MLA
Clarke, Stephen, et al. "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, 2022. https://doi.org/10.1371/journal.pone.0270543
RethinkTHC
RethinkTHC Research Database. "Pilot clinical and pharmacokinetic study of Δ9-Tetrahydrocan..." RTHC-03761. Retrieved from https://rethinkthc.com/research/clarke-2022-pilot-clinical-and-pharmacokinetic
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.