Evidence map›Paper›PMID 34921662›Full record

ArticlePain and therapy2022

Pharmacokinetics, Safety, and Tolerability of a Medicinal Cannabis Formulation in Patients with Chronic Non-cancer Pain on Long-Term High Dose Opioid Analgesia: A Pilot Study.

Yvonne Bonomo, Amanda Norman, Lisa Collins, Helen O'Neill, Peter Galettis, Jane Trinca, Nigel Strauss, Jennifer Martin, David Castle

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.6field-weighted citation impact, top 11% of its field
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

7 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. A Survey of Cannabis Use among Patients with Inflammatory Bowel Disease (IBD).International journal of environmental research and public health · 2023
    Article
  7. Article
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

9 authors at 3 institutions in 1 country.

Yvonne BonomoDepartment of Addiction Medicine, St Vincent's Hospital Melbourne, University of Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia. Yvonne.bonomo@svha.org.au.ORCID http://orcid.org/0000-0003-2583-0687
Amanda NormanDepartment of Addiction Medicine, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.
Lisa CollinsDepartment of Addiction Medicine, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.
Helen O'NeillDepartment of Addiction Medicine, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.
Peter GalettisClinical Pharmacology Laboratory, Faculty of Health and Medicine, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, 2308, Australia.
Jane TrincaBarbara Walker Centre for Pain Management, St Vincent's Hospital Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.
Nigel StraussMillswyn Clinic, 466 Punt Road, South Yarra, VIC, 3141, Australia.
Jennifer MartinSchool of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, Callaghan, NSW, 2308, Australia.
David CastleMental Health, St Vincent's Hospital Melbourne, University of Melbourne, P.O. Box 2900, Fitzroy, VIC, 3065, Australia.
St Vincent's Hospital Melbourne · AUThe University of Melbourne · AUUniversity of Newcastle Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis phase I open-label study examined pharmacokinetics, safety, and tolerability of escalating doses of a novel combination cannabinoid medication (1:1 tetrahydrocannabinol [THC]/cannabidiol [CBD]) in patients with chronic non-cancer pain (CNCP) on high dose opioid analgesia.

methodsNine people with CNCP and oral morphine equivalent daily dose of 60 mg or higher were recruited. Blood concentrations of THC, 11-hydroxytetrahydrocannabinol (OH-THC), 11-nor-9-carboxy-tetrahydrocannabinol (COOH-THC), and CBD were assayed weekly. Concentrations were measured after a single dose of 2.5 mg THC/2.5 mg CBD on day 1, and daily escalating doses up to a single dose of 12.5 mg THC/12.5 mg CBD on day 29. Follow-up was on day 36 after a 7-day washout. Secondary outcome data encompassed pain, mood, and sleep parameters.

resultsThe parent compounds THC, and CBD, and metabolites OH-THC and COOH-THC were detected at most time points. In general, the concentration of all analytes increased until 2 h post-administration, decreasing to approximately pre-dose concentrations by 8 h. There was considerable inter- and intra-individual variability. The study medication was well tolerated. Eight participants reported at least one adverse event (AE), with a total of 62 AEs; most common were euphoric mood, headache, and agitation, none classified as severe. There was no significant change to pain severity self-ratings, nor use of pain medications. Improvements in pain interference scores, mood, and some sleep parameters were observed.

conclusionThe THC/CBD formulation was tolerated well in a group of patients with CNCP. Between-participant variability supports personalized dosing and "start low-go slow" titration. To validate and quantify improvements in secondary efficacy outcomes a randomized placebo-controlled study is needed.

trial registrationAustralian New Zealand Clinical Trials Register (CT-2019-CTN-01224-1).

Indexed as

CBDChronic painMedicinal cannabisPharmacokineticsSafetyTHC

Identifiers

PMID34921662
PMCPMC8861237
OpenAlexW4200456153

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.