Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults

Sponsor

Formula30A LLC (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05743985

Collaborator

(none)

100

Enrollment

Locations

Arm

Anticipated Duration (Months)

14.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol (CBG) in healthy human adults age 21 or over.

The main questions it aims to answer are:

What effect, if any, does daily oral consumption of 50mg of full spectrum CBG have on the mental, physical, and emotional wellbeing of healthy individuals, as measured by self-report Medical Symptom Questionnaire and 36-Item Short Form Health Survey scores?
Is CBG effective at reducing inflammation in the body, as measured by HSCRP, ESR, and PSA inflammatory markers?
Do age, gender, weight, or state of body inflammation have an effect on the perceived efficacy of CBG?
What adverse effects, if any, are associated with CBG use?

Over the course of the 12-week study, participants will:

Take baseline MSQ and SF-36 surveys, as well as a clinical visit with blood draws for HSCRP, ESR, and PSA testing
Consume one (1) 50mg capsule of full spectrum CBG daily by mouth with food for 8 weeks, followed by a 4-week washout period
Complete biweekly SF-36 surveys as well as MSQ surveys every 4 weeks
Attend a clinical visit every 4 weeks for clinical observation and blood draws for HSCRP, ESR, and PSA (male subjects)

Condition or Disease	Intervention/Treatment	Phase
Health, Subjective Inflammatory Response Adverse Effect Side Effect	Other: Cannabigerol	N/A

Detailed Description

BACKGROUND AND CONTEXT

The Cannabis plant has gained significant, and increasing, interest in the medical community due to the therapeutic potential of substances such as Δ9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). However, there are hundreds of different phytocannabinoids, terpenes, and flavonoids present in Cannabis plants, generating complex interactions in the human body. Cannabigerol (CBG) is one phytocannabinoid that has recently garnered a groundswell of media and commercial interest, although scientific literature on CBG is severely lacking compared with published research on Δ9-THC and CBD. Current studies suggest that CBG appears to have characteristics for affinity and activity somewhere between CBD and Δ9-THC, with additional unique interactions with 5-hydroxytryptamine (5-HT1A) receptors and α-2 adrenoceptors. Based on published research, there may be therapeutic potential for CBG in the treatment of neuroinflammatory disorders, inflammatory bowel disease, bacterial infections (such as MRSA), prostate cancer, and dental plaque. Many of these studies, however, indicate a vital need for additional research on the pharmacological effects of human CBG consumption, especially given the increase in its unregulated commercial use. This study will focus on the clinical application of CBG for healthy adults, current knowledge of its possible therapeutic utility, and its potential toxicological hazards.

PROBLEM STATEMENT

Cannabigerol is currently available for purchase in a variety of products and, as with cannabidiol (CBD) before it, many claims are being made about its benefits. Unlike CBD, however, little in-depth research has been performed on this intriguing phytocannabinoid, and much of what is known warrants further investigation to identify potential areas of therapeutic uses and hazards.

RESEARCH QUESTIONS

What effect, if any, does daily oral consumption of 50mg of full spectrum CBG have on the mental, physical, and emotional wellbeing of healthy individuals, as measured by self-report Medical Symptom Questionnaire and 36-Item Short Form Health Survey scores? Is CBG effective at reducing inflammation in the body, as measured by HSCRP, ESR, and PSA inflammatory markers? Do age, gender, weight, or state of body inflammation have an effect on the perceived efficacy of CBG? What adverse effects, if any, are associated with CBG use?

OBJECTIVES

The long-term goal is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol in humans. The objective of the current study is to determine whether clinically applied CBG in 100 healthy adults 21 or over in the United States has an effect on inflammatory markers in the body and/or self-reported physical, mental, and emotional wellbeing. The study has the following sub-objectives:

To provide initial data on the physiological and self-reported psychological effects CBG;
To work towards development of a CBG administration method for easier physician dosage control and oversight;
To review and document current industry practices and research in regard to CBG use;
To outline a conceptual framework for the clinical application of CBG.

The result of this study will be valuable to industry practitioners as well as patient populations in developing a clear pharmacological picture of the efficacy and risks of full spectrum CBG consumption.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50mg CBG Capsule 50mg cannabigerol (CBG) oil capsule taken daily for 8 weeks. Study surveys and bloodwork completed for 12 weeks total, including 8 weeks of CBG treatment and subsequent 4-week washout period	Other: Cannabigerol Hemp-derived full spectrum cannabigerol oil carried in an organic coconut (MCT) oil within hydroxypropyl methylcellulose capsules. Other Names: Formula30A Cannabigerol (CBG) 50mg Capsules Formula30A CBG

Arm

Intervention/Treatment

Experimental: 50mg CBG Capsule

50mg cannabigerol (CBG) oil capsule taken daily for 8 weeks. Study surveys and bloodwork completed for 12 weeks total, including 8 weeks of CBG treatment and subsequent 4-week washout period

Other: Cannabigerol

Hemp-derived full spectrum cannabigerol oil carried in an organic coconut (MCT) oil within hydroxypropyl methylcellulose capsules.

Other Names:

Formula30A Cannabigerol (CBG) 50mg Capsules

Formula30A CBG

Outcome Measures

Primary Outcome Measures

Change from Baseline Medical Symptom Questionnaire (MSQ) Score at 8 weeks [8 weeks]
Change from baseline scores as measured by the Medical Symptom Questionnaire after 8 weeks. A total score of 20 or less is not clinically significant, 20 to 49 indicates mild toxicity, 50 to 99 indicates moderate toxicity, and 100 and above indicates severe toxicity.
Change from Baseline RAND 36-Item Short Form Survey (SF-36) Scores at 8 weeks [8 weeks]
Change from baseline scores as measured by the RAND 36-Item Short Form Survey after 8 weeks. Scores range from 0-100 for the 8 scales included (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health), with higher scores representing a more favorable health state.
Change from Baseline High-Sensitivity C-reactive Protein (hsCRP) at 8 weeks [8 weeks]
Blood concentration, measured in mg/L
Change from Baseline Erythrocyte Sedimentation Rate (ESR) at 8 weeks [8 weeks]
Blood concentration, measured in mm/hour
Change from Baseline Prostate-Specific Antigen (PSA) Score at 8 weeks [Male Subjects] [8 weeks]
Blood concentration, measured in ng/mL

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

In good overall health (as determined by the supervising healthcare provider recommendation as well as no indications of Moderate or Severe conditions on the study measurement tools)
21 years old or over
No conditions determined at risk for adverse reactions to the product ingredients
Research participants with the potential to become pregnant are eligible to be included in the study as long as they are sexually abstinent or using a contraceptive method considered effective.

Exclusion Criteria:

Under the age of 21
Is pregnant or breastfeeding
Initiated or changed use of medication or therapies within 2 weeks prior to the start of the study
Has a history of hepatic compromise (with transaminases of two times the upper limit of normal) or cirrhosis
Is already using recreational marijuana, medical marijuana or other cannabinoid formulations (including CBD)
Has a history of substance or alcohol abuse
Is using High Dose or Extended-Release Narcotics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Hormonal Balance	Arlington	Texas	United States	76016
2	NP Care Clinic	Denton	Texas	United States	76201
3	Infectious Disease Specialists	Edinburg	Texas	United States	78539
4	Modern Medicine	Forney	Texas	United States	75126
5	Texas Gynecology	Frisco	Texas	United States	75034
6	Melville Medicine	Southlake	Texas	United States	76092
7	Java Med	Ceiba		Puerto Rico	00735