Evidence map›Paper›PMID 30791225›Full record

ArticleClinical pharmacology in drug development2019

A Phase 1, Open-Label, Pharmacokinetic Trial to Investigate Possible Drug-Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects.

Gilmour Morrison, Julie Crockett, Graham Blakey, Kenneth Sommerville

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical pharmacology in drug development, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04280289 (CBD Cannabis Extract), which is not on this map. Cited by 99 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 13 pooled it
18.7field-weighted citation impact, top 1% 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.

NCT04280289 early_phase1completednot on this mapstarted 2021, after this paper: background citation

CBD Cannabis Extract: Pharmacokinetic Studies

TypeinterventionalSponsorUniversity of Mississippi, OxfordRan2021 to 2021Enrolled10ConditionsEpilepsyArmscannabidiol extract
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 13 syntheses or guidelines pooled it, 195 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2020
    Pooled it
  13. Pooled it
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

39 more citing papers are in PubMed but not listed here.

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

4 authors at 3 institutions in 1 country.

Gilmour MorrisonGW Research Ltd, Cambridge, UK.
Julie CrockettGW Research Ltd, Cambridge, UK.
Graham Blakeyconsult2deliver, Nottingham, UK.
Kenneth SommervilleGreenwich Biosciences, Inc., Carlsbad, CA, USA.
GW Pharmaceuticals (United Kingdom) · GBRoyal Observatory in Greenwich · GBUniversity of Nottingham · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

GW Pharmaceuticals' formulation of highly purified cannabidiol oral solution is approved in the United States for seizures associated with Lennox-Gastaut and Dravet syndromes in patients aged ≥2 years, for which clobazam, stiripentol, and valproate are commonly used antiepileptic drugs. This open-label, fixed-sequence, drug-drug interaction, healthy volunteer trial investigated the impact of cannabidiol on steady-state pharmacokinetics of clobazam (and N-desmethylclobazam), stiripentol, and valproate; the reciprocal effect of clobazam, stiripentol, and valproate on cannabidiol and its major metabolites (7-hydroxy-cannabidiol [7-OH-CBD] and 7-carboxy-cannabidiol [7-COOH-CBD]); and cannabidiol safety and tolerability when coadministered with each antiepileptic drug. Concomitant cannabidiol had little effect on clobazam exposure (maximum concentration [C

Indexed as

AdultAnticonvulsantsCannabidiolClobazamCytochrome P-450 CYP2C19DioxolanesDrug InteractionsFemaleGenotypeHealthy VolunteersHumansMaleValproic AcidAnticonvulsantsCannabidiolClobazamCYP2C19 protein, humanCytochrome P-450 CYP2C19DioxolanesstiripentolValproic Acidcannabidiolclobazamdrug-drug interactionpharmacokineticsstiripentolvalproate

Identifiers

PMID30791225
PMCPMC6899822
OpenAlexW2915210550

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.