Cannabidiol Liver Safety Clinical Trial

Catalogued

U.S. Food and Drug Administration

About this study

This dataset comes from a randomized, double-blind, placebo-controlled trial of 201 healthy adults who received either cannabidiol (CBD) at 5 mg/kg/day or placebo for 28 days.

It includes repeated measures of liver enzymes, blood counts, endocrine markers, CBD and metabolite concentrations, adverse events, and treatment adherence. The primary outcome was elevation of alanine aminotransferase or aspartate aminotransferase to more than three times the upper limit of normal.

The dataset can support research on CBD-related liver enzyme elevations, potential drug-induced liver injury, endocrine effects, pharmacokinetics, and short-term safety.

Summary statistics

Participants

Date range, conditions covered and surveys completed are not published for a single study: the public aggregate carries a participant count only. Repository-wide breakdowns are on the statistics page.

Last refreshed 4 minutes ago.

Aggregate counts only. Groups smaller than 10 are shown as a range.

Publications using this study

  • Florian J, Salcedo P, Burkhart K, et al. Cannabidiol and liver enzyme level elevations in healthy adults: a randomized clinical trial. JAMA Internal Medicine. 2025;185(9):1070–1078.

Other contributing studies

Administered jointly by Realm of Caring and Johns Hopkins University under NIH award 1UM1DA059000 (NIDA).

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