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NCT04971837 · ClinicalTrials.gov registry record · NA

Interaction Between Cannabidiol, Meal Ingestion, and Liver Function

A NA study of Pharmacokinetics and Metabolism, sponsored by Colorado State University.

Completed
Registry status
NA
Development phase
26
Enrollment target
1
Study location

NCT04971837 is a NA study of Pharmacokinetics and Metabolism that has completed, run by Colorado State University. The registered enrollment target is 26 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04971837, a NA study of Pharmacokinetics and Metabolism, has completed, sponsored by Colorado State University.

COMPLETED
Registry status
NA
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

According to a recent consumer poll, over 20 million Americans regularly use cannabidiol (CBD). Moreover, 64 million Americans (over 25% of the population) report trying CBD at least once within the previous 2 years. Since the passing of the 2018 Agriculture Improvement Act, the use of hemp-derived products, such as CBD, is highly prevalent across North America. The acceleration of the use of CBD has outpaced our understanding of the associated potential risks and benefits, and the way it is processed within the body. In the current proposed project, investigators wish to continue our ongoing collaboration with Caliper Foods, a Colorado-based manufacturer of CBD products. The focus of this project is three-fold: (1) investigators will compare the pharmacokinetics of different formulations of ingestible CBD; (2) investigators will examine the potential two-way interaction between a meal and one formulation of ingestible CBD; and, (3) investigators will examine the influence of different formulations of CBD on markers of liver function.

Conditions Studied

Pharmacokinetics Metabolism Liver Function

Interventions

  • DIETARY_SUPPLEMENT Cannabidiol (CBD) powder formulation
  • DIETARY_SUPPLEMENT Cannabidiol (CBD) Oil based tincture formulation
  • DIETARY_SUPPLEMENT Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation
  • DIETARY_SUPPLEMENT Cannabidiol (CBD) Gum Arabic, sorbitol base formulation
  • DIETARY_SUPPLEMENT Cannabidiol (CBD) Isolate in water formulation

Study Locations (1)

Colorado

  • Colorado State University, Dept. of Health and Exercise Science - Fort Collins

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2021-05-20
Est. Completion 2021-12-09
Phase NA

Sponsor

Colorado State University

94 total trials

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What the Registry Record Tells You About NCT04971837

The ClinicalTrials.gov registry entry for NCT04971837 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (57% lower). The listed sponsor is Colorado State University, which has 94 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 5 interventions - of which Cannabidiol (CBD) powder formulation is the first listed.

NCT04971837 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT04971837 about?

NCT04971837 is a clinical study titled "Interaction Between Cannabidiol, Meal Ingestion, and Liver Function". According to a recent consumer poll, over 20 million Americans regularly use cannabidiol (CBD). Moreover, 64 million Americans (over 25% of the population) report trying CBD at least once within the previous 2 years. Since the passing of the 2018 Agriculture Improvement Act, the use of hemp-derived ...

What is the current status of trial NCT04971837?

This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2021-05-20. Estimated completion is 2021-12-09.

What conditions does trial NCT04971837 study?

This clinical trial studies the following conditions: Pharmacokinetics, Metabolism, Liver Function.

What interventions are being tested in trial NCT04971837?

The interventions under investigation include: Cannabidiol (CBD) powder formulation (DIETARY_SUPPLEMENT), Cannabidiol (CBD) Oil based tincture formulation (DIETARY_SUPPLEMENT), Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation (DIETARY_SUPPLEMENT), Cannabidiol (CBD) Gum Arabic, sorbitol base formulation (DIETARY_SUPPLEMENT), Cannabidiol (CBD) Isolate in water formulation (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04971837?

This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04971837 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.