{"id":2639,"date":"2020-10-13T10:59:47","date_gmt":"2020-10-12T23:59:47","guid":{"rendered":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/cannabidiol-and-abnormal-liver-chemistries-in-healthy-adults-results-of-a-phase-1-clinical-trial\/"},"modified":"2025-11-12T21:00:31","modified_gmt":"2025-11-12T10:00:31","slug":"cannabidiol-and-abnormal-liver-chemistries-in-healthy-adults-results-of-a-phase-1-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/cannabidiol-and-abnormal-liver-chemistries-in-healthy-adults-results-of-a-phase-1-clinical-trial\/","title":{"rendered":"Cannabidiol and Abnormal Liver Chemistries in Healthy Adults: Results of a Phase 1 Clinical Trial"},"content":{"rendered":"<p><strong><em>Abstract<\/em><\/strong><\/p>\n<p>Liver safety concerns were raised in randomized controlled trials of cannabidiol (CBD) in patients with Lennox\u2010Gastaut 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&nbsp;weeks and to investigate any correlation between transaminase elevations and baseline characteristics, pharmacogenetic, and pharmacokinetic data. Sixteen healthy adults were enrolled in a phase 1, open\u2010label, fixed single\u2010sequence drug\u2010drug interaction trial to investigate the effect of repeated dose administration of CBD (1500&nbsp;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 5 (31%) participants, the value exceeded&nbsp;5\u00d7 ULN, therefore meeting the international consensus criteria for drug\u2010induced 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\u20134 weeks of initial exposure to CBD. Among the 6 participants with ALT elevations who were discontinued from the protocol, some had symptoms consistent with hepatitis or hypersensitivity.<\/p>\n<p>We conclude that healthy adults consuming CBD may experience elevations in serum ALT consistent with drug\u2010induced liver injury. Given the demonstrated inter\u2010individual variation in susceptibility, clinicians should be alert to this potential effect from CBD, which is increasingly available in various non\u2010prescription forms and doses to consumers.<\/p>\n<p><strong><a href=\"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1002\/cpt.2071\" target=\"_blank\" rel=\"noopener\" class=\"button\">For complete research<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Abstract Liver safety concerns were raised in randomized controlled trials of cannabidiol (CBD) in patients with Lennox\u2010Gastaut 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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":"","_wp_rev_ctl_limit":""},"categories":[15],"tags":[77],"class_list":["post-2639","post","type-post","status-publish","format-standard","hentry","category-cannabis-as-medicine","tag-cannabis-as-medicine"],"_links":{"self":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/posts\/2639","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/comments?post=2639"}],"version-history":[{"count":0,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/posts\/2639\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/media?parent=2639"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/categories?post=2639"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.dalgarnoinstitute.org.au\/wp_site\/wp-json\/wp\/v2\/tags?post=2639"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}