Evidence map›Paper›PMID 39302982›Full record

ArticlePloS one2024

A multi-centre, tolerability study of a cannabidiol-enriched Cannabis Herbal Extract for chronic headaches in adolescents: The CAN-CHA protocol.

Manik Chhabra, Evan C Lewis, Robert Balshaw, Breanne Stewart, Zina Zaslawski, Trinity Lowthian, Zahra Alidina, Melila Chesick-Gordis, Wenli Xie, Britt I Drögemöller and 18 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05337033 (A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT05337033 phase2recruitingnot on this map

A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial

TypeinterventionalSponsorUniversity of ManitobaRan2024 to 2025Enrolled20ConditionsChronic MigraineArmsMPL-001
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

28 authors.

Manik ChhabraDepartment of Pharmacology & Therapeutics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
Evan C LewisNorth Toronto Neurology, Toronto, Ontario, Canada.ORCID 0000-0001-9024-150X
Robert BalshawGeorge and Fay Yee Centre for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada.
Breanne StewartQuality Management in Clinical Research (QMCR), University of Alberta, Edmonton, Alberta, Canada.
Zina ZaslawskiGeorge and Fay Yee Centre for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada.
Trinity LowthianYouth Research Partners, Childhood Cannabinoid Therapeutics (C4T), Ottawa, Ontario, Canada.
Zahra AlidinaYouth Research Partners, Childhood Cannabinoid Therapeutics (C4T), Holland Landing, Ontario, Canada.
Melila Chesick-GordisYouth Research Partners, Childhood Cannabinoid Therapeutics (C4T), Vancouver, British Columbia, Canada.
Wenli XieMaternal Infant Child and Youth Research Network (MICYRN), Vancouver, British Columbia, Canada.
Britt I DrögemöllerDepartment of Biochemistry and Medical Genetics, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
Galen E B WrightDepartment of Pharmacology & Therapeutics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
Kathryn A BirnieDepartment of Anesthesiology, Perioperative and Pain Medicine, University of Calgary, Calgary, Alberta, Canada.ORCID 0000-0002-8223-8834
Katelynn E BoernerDepartment of Pediatrics, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.ORCID 0000-0003-1652-4813
Vivian W L TsangMaternal Infant Child and Youth Research Network (MICYRN), Vancouver, British Columbia, Canada.ORCID 0000-0001-9401-008X
Samantha Lee IrwinUniversity of Texas at Austin Pediatric Neurosciences at Dell Children's Pediatric Headache Program, Austin, Texas, United States of America.
Daniela PohlDivision of Neurology, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.
Alexander G WeilPediatric Neurosurgery, Department of Surgery, Sainte Justine Hospital, University of Montreal, Montreal, Quebec, Canada.
Erick SellDivision of Neurology, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.
Erika PenzDepartment of Medicine, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.ORCID 0000-0003-2610-8450
Amy Robson-MacKayDepartment of Psychiatry, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Sophia MbabaaliGeorge and Fay Yee Centre for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada.
Stephanie BlackmanDepartment of Anesthesia, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Shanlea GordonDepartment of Pediatrics, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.ORCID 0000-0003-2615-8060
Jane AlcornCannabinoid Research Initiative of Saskatchewan, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Richard J HuntsmanCannabinoid Research Initiative of Saskatchewan, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Tim F OberlanderDepartment of Pediatrics, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.
G Allen FinleyDepartment of Anesthesia, Pain Management and Perioperative Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Lauren E KellyDepartment of Pharmacology & Therapeutics, Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCannabis products have been used in the management of headaches in adults and may play a role in pediatric chronic pain. Canadian pediatricians report increasing use of cannabis for the management of chronic headaches, despite no well-controlled studies to inform its dosing, safety, and effectiveness. The aim of our clinical trial is to determine the dosing and safety of a Cannabidiol (CBD)-enriched Cannabis Herbal Extract (CHE) for the treatment of chronic headaches in adolescents. METHODS AND ANALYSIS: Youth, parents, and an expert steering committee co-designed this tolerability study. Twenty adolescents (aged 14 to 17 years), with a chronic migraine diagnosis for more than 6 months that has not responded to other therapies will be enrolled into an open label, dose escalation study across three Canadian sites. Study participants will receive escalating doses of a CBD-enriched CHE (MPL-001 with a THC:CBD of 1:25), starting at 0.2-0.4 mg/kg of CBD per day and escalating monthly up to 0.8-1.0 mg/kg of CBD per day. The primary objective of this study is to determine the safety and tolerability of CBD-enriched CHE in adolescents with chronic migraine. Secondary objectives of this study will inform the development of subsequent randomized controlled trials and include investigating the relationship between the dose escalation and change in the frequency of headache, impact and intensity of pain, changes in sleep, mood, function, and quality of life. Exploratory outcomes include investigating steady-state trough plasma levels of bioactive cannabinoids and investigating how pharmacogenetic profiles affect cannabinoid metabolism among adolescents receiving CBD-enriched CHE. DISCUSSION: This protocol was co-designed with youth and describes a tolerability clinical trial of CBD-enriched CHE in adolescents with chronic headaches that have not responded to conventional therapies. This study is the first clinical trial on cannabis products in adolescents with chronic headaches and will inform the development of future comparative effectiveness clinical trials.

trial registrationCAN-CHA trial is registered with ClinicalTrials.gov with a number of register NCT05337033.

Indexed as

CannabidiolPlant ExtractsAdolescentCanadaCannabisClinical Trials, Phase I as TopicFemaleHeadache DisordersHumansMaleMigraine DisordersMulticenter Studies as TopicCannabidiolPlant Extracts

Identifiers

PMID39302982
PMCPMC11414974

What OpenQuestion holds

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Registered trials

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.