Evidence map›Paper›PMID 32048179›Full record

Observational studyClinical pharmacokinetics2020

Disposition of Oral Cannabidiol-Rich Cannabis Extracts in Children with Epilepsy.

George Sam Wang, David W A Bourne, Jost Klawitter, Cristina Sempio, Kevin Chapman, Kelly Knupp, Michael F Wempe, Laura Borgelt, Uwe Christians, Jan Leonard and 2 more

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical pharmacokinetics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02447198 (Cannabidiol), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 20% 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.

NCT02447198 completednot on this map

Cannabidiol (CBD) and Pediatric Epilepsy

TypeobservationalSponsorUniversity of Colorado, DenverRan2015 to 2018Enrolled42ConditionsEpilepsy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Determination of ΔForensic toxicology · 2024
    Article
  3. Review
  4. Article
  5. 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

12 authors at 4 institutions in 1 country.

George Sam WangSection of Emergency Medicine and Medical Toxicology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, 13123 E 16th Ave B251, Aurora, CO, 8004, USA. George.wang@childrenscolorado.org.
David W A BourneDepartment of Pharmaceutical Sciences, Center for Translational Pharmacokinetics and Pharmacogenomics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Jost KlawitteriC42 Clinical Research and Development, Department of Anesthesiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Cristina SempioiC42 Clinical Research and Development, Department of Anesthesiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Kevin ChapmanDepartment of Neurology and Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Kelly KnuppDepartment of Neurology and Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Michael F WempeDepartment of Pharmaceutical Sciences, Center for Translational Pharmacokinetics and Pharmacogenomics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Laura BorgeltDepartments of Clinical Pharmacy and Family Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Uwe ChristiansiC42 Clinical Research and Development, Department of Anesthesiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Jan LeonardSection of Emergency Medicine and Medical Toxicology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, 13123 E 16th Ave B251, Aurora, CO, 8004, USA.
Kennon HeardDepartment of Emergency Medicine, University of Colorado Anschutz Medical Campus, University of Colorado Hospital, Aurora, CO, USA.
Lalit BajajSection of Emergency Medicine and Medical Toxicology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Anschutz Medical Campus, 13123 E 16th Ave B251, Aurora, CO, 8004, USA.
University of Colorado Anschutz Medical Campus · USChildren's Hospital Colorado · USUniversity of Colorado Denver · USUniversity of Colorado Hospital · US

Funding

Impact of Marijuana Legalization on Opioid Prescribing and Poisonings in ColoradoR01DA045051 · NIDA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI PACULA, ROSALIE LICCARDO · 2018 to 2020
$1.7M
NIDA NIH HHS R01 DA045051
6 · The paper itself

Abstract

BACKGROUND AND

objectivesDespite limited evidence, cannabidiol-rich cannabis extracts have been popularly used in pediatrics. With increased use, it is critical to determine basic pharmacokinetic parameters of cannabidiol in these extracts in the pediatric population. The objective of this study was to determine the disposition of oral cannabidiol cannabis extracts and drug interactions in children with pediatric epilepsy.

methodsWe conducted a prospective observational study evaluating the disposition of oral cannabidiol in children (< 18 years of age) receiving cannabidiol extracts for epilepsy. Subjects underwent serial blood draws after oral cannabidiol administration. Cannabidiol and metabolites, along with anticonvulsant concentrations were determined.

resultsTwenty-nine patients had sufficient pharmacokinetic data and were included in the analysis. Mean age was 9.7 years (standard deviation 4.3) and 17 patients (59%) were male. Median peak plasma cannabidiol concentrations was 13.1 ng/mL (interquartile range 6.8-39.3 ng mL); median time to peak of 2.0 h (interquartile range 2.0-4.0 h). Mean acute elimination half-life of oral cannabidiol was 6.2 h (standard deviation 1.8 h). There was an observed half-life of degradation of 533 days noted for cannabidiol concentrations when stored for 0.6-3.1 years. There was some impact on cannabidiol pharmacokinetic parameters when cannabidiol was co-administered with zonisamide (elimination rate constant and V1) and levetiracetam (elimination rate constant).

conclusionsIn pediatric patients using oral cannabidiol-rich cannabis extract for epilepsy, the time to peak concentration of plasma cannabidiol and average acute elimination half-life were shorter than those reported for adults. Co-administration of zonisamide and levetiracetam had some impact on cannabidiol pharmacokinetic parameters. There was an observed degradation of plasma cannabidiol in long-term storage. CLINICAL REGISTRATION: ClinicalTrials.gov Identifer no. NCT02447198.

Indexed as

AnticonvulsantsCannabidiolEpilepsyPlant ExtractsCannabisChildFemaleHumansMaleAnticonvulsantsCannabidiolPlant Extracts

Identifiers

PMID32048179
OpenAlexW3006625698

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.