Nanoparticle CBD oral spray was safe and well-tolerated in a small pilot trial
A nanoparticle CBD oro-buccal spray achieved plasma concentrations comparable to other commercial formulations with no adverse effects in a small randomized trial of 16 healthy participants.
Quick Facts
What This Study Found
The nanoparticle CBD spray met primary outcomes for safety, tolerability, and pharmacokinetics. Peak CBD concentration occurred at 60 minutes for both 6 mg and 18 mg doses. Half-life was 1.23 hours for the low dose and 5.45 hours for the high dose. No adverse inflammatory effects were reported.
Key Numbers
Participants: 16 (12 CBD, 4 placebo). Doses: 6 mg and 18 mg CBD. Peak time: 60 min for both doses. Half-life: 1.23 h (6 mg), 5.45 h (18 mg). AUC: 0.87 ng h/mL (6 mg), 8.9 ng h/mL (18 mg). THC per high dose: 0.72 mg.
How They Did This
Randomized, single-blinded, placebo-controlled pilot study. 12 participants received CBD spray (2 sprays on day 1, 6 sprays on day 2) and 4 received placebo, administered to alternating cheeks. Blood samples collected for pharmacokinetic profiling.
Why This Research Matters
Oro-buccal delivery with nanoparticle technology could improve CBD bioavailability and onset time compared to traditional oral formulations.
The Bigger Picture
CBD delivery technology continues to evolve, with nanoparticle formulations representing one approach to improving the notoriously poor oral bioavailability of cannabinoids.
What This Study Doesn't Tell Us
Very small sample (n=16). Single-blinded rather than double-blinded. Only healthy participants, no disease population. Short two-day dosing period.
Questions This Raises
- ?How does this nanoparticle formulation compare head-to-head with standard CBD oil?
- ?Would repeated dosing change the pharmacokinetic profile?
Trust & Context
- Key Stat:
- Peak CBD concentration reached at 60 minutes via oral spray
- Evidence Grade:
- Randomized and placebo-controlled but very small sample and short duration.
- Study Age:
- Published in 2021.
- Original Title:
- A pilot safety, tolerability and pharmacokinetic study of an oro-buccal administered cannabidiol-dominant anti-inflammatory formulation in healthy individuals: a randomized placebo-controlled single-blinded study.
- Published In:
- Inflammopharmacology, 29(5), 1361-1370 (2021)
- Authors:
- Vitetta, Luis(2), Butcher, Belinda, Henson, Jeremy D(2), Rutolo, David, Hall, Sean
- Database ID:
- RTHC-03597
Evidence Hierarchy
Participants are randomly assigned to treatment or placebo groups to test cause and effect.
What do these levels mean? →Frequently Asked Questions
What is a nanoparticle CBD formulation?
A water-soluble form of CBD created using micellular technology to produce very small particles, potentially improving absorption compared to oil-based CBD products.
How fast does the oral spray work?
CBD reached peak plasma concentration at 60 minutes for both the low (6 mg) and high (18 mg) doses when sprayed inside the cheek.
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Cite This Study
https://rethinkthc.com/research/RTHC-03597APA
Vitetta, Luis; Butcher, Belinda; Henson, Jeremy D; Rutolo, David; Hall, Sean. (2021). A pilot safety, tolerability and pharmacokinetic study of an oro-buccal administered cannabidiol-dominant anti-inflammatory formulation in healthy individuals: a randomized placebo-controlled single-blinded study.. Inflammopharmacology, 29(5), 1361-1370. https://doi.org/10.1007/s10787-021-00859-y
MLA
Vitetta, Luis, et al. "A pilot safety, tolerability and pharmacokinetic study of an oro-buccal administered cannabidiol-dominant anti-inflammatory formulation in healthy individuals: a randomized placebo-controlled single-blinded study.." Inflammopharmacology, 2021. https://doi.org/10.1007/s10787-021-00859-y
RethinkTHC
RethinkTHC Research Database. "A pilot safety, tolerability and pharmacokinetic study of an..." RTHC-03597. Retrieved from https://rethinkthc.com/research/vitetta-2021-a-pilot-safety-tolerability
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.