Evidence map›Paper›PMID 34357480›Full record

Trial reportInflammopharmacology2021

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.

Luis Vitetta, Belinda Butcher, Jeremy D Henson, David Rutolo, Sean Hall

Abstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Inflammopharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Review
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  5. Medicinal Cannabis and the Intestinal Microbiome.Pharmaceuticals (Basel, Switzerland) · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Luis VitettaMedlab Clinical Ltd, Alexandria, NSW, 2015, Australia. luis.vitetta@sydney.edu.au.ORCID http://orcid.org/0000-0002-7490-9298
Belinda ButcherWriteSource Medical Pty Ltd., Lane Cove, Sydney, NSW, 2066, Australia.ORCID http://orcid.org/0000-0002-1415-4065
Jeremy D HensonMedlab Clinical Ltd, Alexandria, NSW, 2015, Australia.ORCID http://orcid.org/0000-0002-1594-9310
David RutoloMedlab Clinical Ltd, Alexandria, NSW, 2015, Australia.
Sean HallMedlab Clinical Ltd, Alexandria, NSW, 2015, Australia.ORCID http://orcid.org/0000-0003-0090-7895

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe cannabis plant presents a complex biochemical unit of over 500 constituents of which 70 or more molecules have been classified as cannabinoids binding to cannabinoid receptors. The study aimed to investigate the safety, tolerability, and preliminary pharmacokinetics of a nanoparticle CBD formulation.

methodsThe cannabis-based medicine was elaborated with a micellular technology, to produce a water-soluble nanoparticle CBD-dominant anti-inflammatory cannabis medicine (MDCNB-02). On day one, 12 participants administered 2 sprays and on day 2 administered 6 sprays to alternating right and left cheeks [18 mg of CBD and 0.72 mg of THC]. Four other participants administered 2 and 6 sprays on days 1 and 2, respectively of a nanoparticle placebo.

resultsThe study met the primary outcomes of safety, tolerability, and preliminary pharmacokinetics of a standardized CBD-dominant anti-inflammatory extract for oro-buccal administration. Bioavailability of a 6 mg and 18 mg dose of CBD (median IQR) was 0.87 and 8.9 ng h mL

conclusionThe oro-buccal nanoparticle formulation achieved plasma concentrations that were largely comparable to other commercial and investigated formulations relative to the concentrations administered. Moreover, there were no reports of adverse effects associated with unfavorable inflammatory sequalae.

Indexed as

NanoparticlesAdministration, OralAdultAnti-Inflammatory AgentsBiological AvailabilityCannabidiolDose-Response Relationship, DrugFemaleHalf-LifeHumansMalePilot ProjectsSolubilityYoung AdultAnti-Inflammatory AgentsCannabidiolCannabidiolNanoparticlesOro-buccalPharmacokineticsSafetyTolerability

Identifiers

PMID34357480

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.