Evidence map›Paper›PMID 33022751›Full record

ArticleClinical pharmacology and therapeutics2021

Cannabidiol and Abnormal Liver Chemistries in Healthy Adults: Results of a Phase I Clinical Trial.

Paul B Watkins, Rachel J Church, Jie Li, Volker Knappertz

Open access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical pharmacology and therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 2 pooled it
8.4field-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.

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

54 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Update of the statement on safety of cannabidiol as a novel food.EFSA journal. European Food Safety Authority · 2026
    Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Carvone derived cannabidiol enantiomers as novel anticonvulsants.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025
    Article
  16. UGT2B7-mediated drug-drug interaction between cannabinoids and hydromorphone.Drug metabolism and disposition: the biological fate of chemicals · 2025
    Article
  17. Article
  18. Article
  19. Article
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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

4 authors at 1 institution in 1 country.

Paul B WatkinsDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy and Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Rachel J ChurchDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy and Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Jie LiGreenwich Biosciences, 5750 Fleet St Ste 200, Carlsbad, CA, USA.
Volker KnappertzGreenwich Biosciences, 5750 Fleet St Ste 200, Carlsbad, CA, USA.
University of North Carolina at Chapel Hill · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Liver safety concerns were raised in randomized controlled trials of cannabidiol (CBD) in patients with Lennox-Gastaut and Dravet syndromes, but the relevance of these concerns to healthy adults consuming CBD is unclear. The objective of this manuscript is to report on liver safety findings from healthy adults who received therapeutic daily doses of CBD for ~ 3.5 weeks and to investigate any correlation between transaminase elevations and baseline characteristics, pharmacogenetic, and pharmacokinetic data. Sixteen healthy adults were enrolled in a phase I, open-label, fixed single-sequence drug-drug interaction trial to investigate the effect of repeated dose administration of CBD (1,500 mg/day) on cytochrome P450 (CYP) 1A2 activity. Seven (44%) participants experienced peak serum alanine aminotransferase (ALT) values greater than the upper limit of normal (ULN). For five (31%) participants, the value exceeded 5 × ULN, therefore meeting the international consensus criteria for drug-induced liver injury. There was no correlation between transaminase elevations and baseline characteristics, CYP2C19 genotype, or CBD plasma concentrations. All ALT elevations above the ULN began within 2-4 weeks of initial exposure to CBD. Among the six participants with ALT elevations who were discontinued from the protocol, some had symptoms consistent with hepatitis or hypersensitivity. We conclude that healthy adults consuming CBD may experience elevations in serum ALT consistent with drug-induced liver injury. Given the demonstrated interindividual variation in susceptibility, clinicians should be alert to this potential effect from CBD, which is increasingly available in various nonprescription forms and doses to consumers.

Indexed as

AdultAlanine TransaminaseCaffeineCannabidiolChemical and Drug Induced Liver InjuryCytochrome P-450 CYP1A2Cytochrome P-450 CYP2C19Drug InteractionsFemaleHumansMaleAlanine TransaminaseCaffeineCannabidiolCYP1A2 protein, humanCYP2C19 protein, humanCytochrome P-450 CYP1A2Cytochrome P-450 CYP2C19

Identifiers

PMID33022751
PMCPMC8246741
OpenAlexW3092159212

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.