Hemp 15 mg & 50 mg Capsule Absorption

• Sponsor: Gaia Herbs Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05076890
• Collaborator: Appalachian College of Pharmacy (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.2
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Absorption; Chemicals	Dietary Supplement: 15 mg/g Full Spectrum Hemp Extract; Dietary Supplement: 50 mg/g Full Spectrum Hemp Extract	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Hemp 15 mg & 50 mg Capsule Absorption
• Actual Study Start Date: Aug 26, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 15 mg/g Full Spectrum Hemp Extract A single capsule of 15 mg/g Full Spectrum Hemp Extract will be delivered.	Dietary Supplement: 15 mg/g Full Spectrum Hemp Extract; HPMC capsules containing full spectrum standardized hemp extract in liquid form.
Experimental: 50 mg/g Full Spectrum Hemp Extract A single capsule of 50 mg/g Full Spectrum Hemp Extract will be delivered.	Dietary Supplement: 50 mg/g Full Spectrum Hemp Extract; HPMC capsules containing full spectrum standardized hemp extract in liquid form.

Outcome Measures

Primary Outcome Measures

1. Time to maximum plasma concentration [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 Outcome Measures

1. Detectable THC [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 Outcome Measures

1. Present in measurable amount over time [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Provision of signed and dated informed consent form.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Ages 18 - 65.

4. In good general health as evidenced by medical history as indicated by oral confirmation of study participant.

5. 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.

6. Ability and willingness to abstain from alcohol use for 12 hours prior to the first clinical visit.

7. Cannabis and CBD naïve for 60 days or more prior to enrolling in the study.

8. Ability and willingness to abstain from food for 6 hours prior to the first clinical visit.

Exclusion Criteria:

1. Current use of regular medication for a chronic condition.

2. Current pregnancy or lactation.

3. Plans to become pregnant during the intended duration of the study.

4. Known allergic reactions to hemp flower.

5. Known severe food allergies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Appalachian College of Pharmacy	Oakwood	Virginia	United States	24631

Sponsors and Collaborators

• Gaia Herbs Inc.
• Appalachian College of Pharmacy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gaia Herbs Inc.
• ClinicalTrials.gov Identifier: NCT05076890
• Other Study ID Numbers: Gaia-19002
• First Posted: Oct 13, 2021
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 9, 2022