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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: Completed NA study of Pharmacokinetics and Metabolism, sponsored by Colorado State University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The different formulations will be standardized for CBD dose (30 mg) but will differ in their preparation (e.g. water vs. fat-soluble). At the 5 randomized Visits Not Including A Test Meal venous blood will be sampled at standardized intervals over 4-hours to calculate Tmax (minutes).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2021-12-09 |
| Phase | NA |
What the finished NCT04971837 record still lists
NCT04971837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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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