NCT04997616

Brief Summary

Levels of major cannabinoid and cannabinoid metabolites (i.e., CBD, CBD-OH) will be determined in the plasma of healthy volunteers following 10 days of Happy Lane Hemp Extract/CBD soft gels (25 mg per capsule) supplementation using liquid chromatography-mass spectrometry (LCMS).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 3, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

August 2, 2021

Last Update Submit

January 3, 2023

Conditions

Healthy

Keywords

CannabidiolHemp-based

Outcome Measures

Primary Outcomes (5)

  • Amount of CBD in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

    Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of CBD in the plasma samples.

    13 days

  • Amount of CBD-OH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

    Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of CBD-OH in the plasma samples.

    13 days

  • Amount of THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

    Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of THC in the plasma samples.

    13 days

  • Amount of THC-COOH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

    Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of THC-COOH in the plasma samples.

    13 days

  • Amount of 11-OH-THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS

    Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. LCMS will be used to measure the presence of 11-OH-THC in the plasma samples.

    13 days

Study Arms (2)

25 mg/day dose of Happy Lane CBD (Lower Dose)

EXPERIMENTAL

One 25 mg Happy Lane CBD gel capsule per day (25 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days.

Dietary Supplement: Happy Lane Hemp Extract/CBD soft gels (25 mg/capsule)

50 mg/day dose of Happy Lane CBD (Larger Dose)

EXPERIMENTAL

Two 25 mg Happy Lane CBD gel capsules per day (50 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days. Both capsules will be taken at the same time as each other.

Dietary Supplement: Happy Lane Hemp Extract/CBD soft gels (25 mg/capsule)

Interventions

Happy Lane Hemp Extract/CBD soft gels (25 mg/capsule)DIETARY_SUPPLEMENT

Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). Study participants will be taking gel capsules for 10 consecutive days. At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. Major plant cannabinoids and cannabinoid metabolites in each blood specimen will be determined using liquid chromatography-mass spectrometry.

25 mg/day dose of Happy Lane CBD (Lower Dose)50 mg/day dose of Happy Lane CBD (Larger Dose)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and Females, between 18- and 45-years old, inclusive
  • Ability to provide consent for oneself, including:
  • Attestation not to use other cannabinoid-containing product(s) throughout the duration of the study
  • Attestation not to use prescription or over the counter medication(s) and/or supplements throughout the duration of the study

You may not qualify if:

  • Self-reported use of any cannabinoids (i.e., CBD, THC) within the last 4 weeks.
  • Use of any prescription (or over the counter) medication or supplements during the study or in the 24 hours before enrollment in the study
  • Serious illness (e.g., abnormal liver or kidney function, cardiovascular disease, diabetes, etc.)
  • Any other condition that in the opinion of the investigator might interfere with the safe conduct of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Study Officials

  • Igor Koturbash, MD, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

August 9, 2021

Study Start

January 3, 2023

Primary Completion

January 3, 2023

Study Completion

January 3, 2023

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)