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OpenTrials
Completed

NCT Number: NCT05076890

Hemp 15 mg & 50 mg Capsule Absorption

This study is intended to investigate the absorption of cannabidiol (CBD) and cannabidiol acid (CBD-A) in plasma from an oral delivery of a single dose of full spectrum hemp extract at two concentrations over a 4-hour timeline.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Appalachian College of Pharmacy

Oakwood, Virginia, 24631, United States

About this study

This study is designed to determine the time to maximum plasma concentration of CBD and CBD-A after an oral dose of standardized full spectrum hemp extract over a 4-hour timeline. This study is designed to include two arms. Each arm will be delivered a different concentration of standardized full spectrum hemp extract, either 15 mg or 50 mg. Throughout the course of the study all participants will be asked to provide four (4) plasma samples, 10 randomly selected participants will be asked to provide five (5) plasma samples. Samples will then be evaluated using a validated LC-MS/MS method to develop a blood concentration time curve in order to determine time to reach maximum blood concentration. This trial is double-blinded with two arms enrolling only healthy individuals. The participants randomized for a fifth blood draw will be randomly selected from these two arms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Ages 18 - 65.
  • In good general health as evidenced by medical history as indicated by oral confirmation of study participant.
  • Ability and willingness to suspend the use of any other herbal dietary supplements for 48 hours prior the first clinical visit associated with this study.
  • Ability and willingness to abstain from alcohol use for 12 hours prior to the first clinical visit.
  • Cannabis and CBD naïve for 60 days or more prior to enrolling in the study.
  • Ability and willingness to abstain from food for 6 hours prior to the first clinical visit.

Exclusion criteria

  • Current use of regular medication for a chronic condition.
  • Current pregnancy or lactation.
  • Plans to become pregnant during the intended duration of the study.
  • Known allergic reactions to hemp flower.
  • Known severe food allergies.

Treatment and study plan

15 mg/g Full Spectrum Hemp Extract

Dietary Supplement

HPMC capsules containing full spectrum standardized hemp extract in liquid form.

50 mg/g Full Spectrum Hemp Extract

Dietary Supplement

HPMC capsules containing full spectrum standardized hemp extract in liquid form.

Primary outcomes

  1. Time to maximum plasma concentration

    Time frame: Over 4 hours

    To determine the time to maximum plasma concentration of cannabidiol (CBD) and cannabidiol acid (CBD-A) from an oral delivery of a single dose of standardized 15 mg or 50 mg full spectrum hemp extract

Secondary outcomes

  1. Detectable THC

    Time frame: Over 4 hours

    To determine if the oral delivery of a full spectrum hemp extract standardized to less than 0.3% ∆^9- tetrahydrocannabinol (THC) results in detectable amounts of THC in plasma.

Other outcomes

  1. Present in measurable amount over time

    Time frame: 7 - 10 days

    To determine if CBD, CBD-A, or THC are present 7 to 10 days after a single oral dose of 15 mg or 50 mg standardized full spectrum hemp extract.

Sponsors and collaborators

Lead sponsor

Gaia Herbs Inc.

Industry

Collaborators

  • Appalachian College of Pharmacy

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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