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Health, SubjectiveNCT05743985

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

A study testing Cannabigerol in people with Health, Subjective and Inflammatory Response, run by Formula30A LLC at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
Cannabigerol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
6 sitesin 2 countries
Study dates
1 Aug 2022to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites
  • Institute for Hormonal Balance

    Arlington, Texas, 76016

  • NP Care Clinic

    Denton, Texas, 76201

  • Infectious Disease Specialists

    Edinburg, Texas, 78539

  • Modern Medicine

    Forney, Texas, 75126

  • Melville Medicine

    Southlake, Texas, 76092

Other trials in United States

Puerto Rico1 site
  • Java Med

    Ceiba, Puerto Rico, 00735

Other trials in Puerto Rico

About this study

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:

Read more
  • 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)
Read the 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:

  1. To provide initial data on the physiological and self-reported psychological effects CBG;
  2. To work towards development of a CBG administration method for easier physician dosage control and oversight;
  3. To review and document current industry practices and research in regard to CBG use;
  4. 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.

Being tested
Cannabigerol
Keywords
Endocannabinoid System, Cannabis, Cannabigerol, CBG, Cannabinoids, Cannabinoid, Hemp
Medical subject headings
Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabigerolOther

    Also called Formula30A Cannabigerol (CBG) 50mg Capsules, Formula30A CBG

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

Study groups in NCT05743985
Study groupRoleWhat they receive
50mg CBG CapsuleExperimental50mg 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
Receives: Other: Cannabigerol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Medical Symptom Questionnaire (MSQ) Score at 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.

    Measured: 8 weeks

  2. Change from Baseline RAND 36-Item Short Form Survey (SF-36) Scores at 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.

    Measured: 8 weeks

  3. Change from Baseline High-Sensitivity C-reactive Protein (hsCRP) at 8 weeks

    Blood concentration, measured in mg/L

    Measured: 8 weeks

  4. Change from Baseline Erythrocyte Sedimentation Rate (ESR) at 8 weeks

    Blood concentration, measured in mm/hour

    Measured: 8 weeks

  5. Change from Baseline Prostate-Specific Antigen (PSA) Score at 8 weeks [Male Subjects]

    Blood concentration, measured in ng/mL

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start1 Aug 2022
  3. Primary completion31 Dec 2023
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05743985
Sponsor's protocol ID
F30A-CBG-EAS2022
Status last verified
Feb 2025
First submitted
15 Feb 2023
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication, shared upon request.

Publications

  • Nachnani R, Raup-Konsavage WM, Vrana KE. The Pharmacological Case for Cannabigerol. J Pharmacol Exp Ther. 2021 Feb;376(2):204-212. doi: 10.1124/jpet.120.000340. Epub 2020 Nov 9.

    PubMed 33168643
  • Navarro G, Varani K, Reyes-Resina I, Sanchez de Medina V, Rivas-Santisteban R, Sanchez-Carnerero Callado C, Vincenzi F, Casano S, Ferreiro-Vera C, Canela EI, Borea PA, Nadal X, Franco R. Cannabigerol Action at Cannabinoid CB1 and CB2 Receptors and at CB1-CB2 Heteroreceptor Complexes. Front Pharmacol. 2018 Jun 21;9:632. doi: 10.3389/fphar.2018.00632. eCollection 2018.

    PubMed 29977202
  • De Petrocellis L, Ligresti A, Moriello AS, Allara M, Bisogno T, Petrosino S, Stott CG, Di Marzo V. Effects of cannabinoids and cannabinoid-enriched Cannabis extracts on TRP channels and endocannabinoid metabolic enzymes. Br J Pharmacol. 2011 Aug;163(7):1479-94. doi: 10.1111/j.1476-5381.2010.01166.x.

    PubMed 21175579
  • Echeverry C, Prunell G, Narbondo C, de Medina VS, Nadal X, Reyes-Parada M, Scorza C. A Comparative In Vitro Study of the Neuroprotective Effect Induced by Cannabidiol, Cannabigerol, and Their Respective Acid Forms: Relevance of the 5-HT1A Receptors. Neurotox Res. 2021 Apr;39(2):335-348. doi: 10.1007/s12640-020-00277-y. Epub 2020 Sep 4.

    PubMed 32886342
  • Fellous T, De Maio F, Kalkan H, Carannante B, Boccella S, Petrosino S, Maione S, Di Marzo V, Iannotti FA. Phytocannabinoids promote viability and functional adipogenesis of bone marrow-derived mesenchymal stem cells through different molecular targets. Biochem Pharmacol. 2020 May;175:113859. doi: 10.1016/j.bcp.2020.113859. Epub 2020 Feb 14.

    PubMed 32061773
  • Crocq MA. History of cannabis and the endocannabinoid system . Dialogues Clin Neurosci. 2020 Sep;22(3):223-228. doi: 10.31887/DCNS.2020.22.3/mcrocq.

    PubMed 33162765
  • Russo EB, Cuttler C, Cooper ZD, Stueber A, Whiteley VL, Sexton M. Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. Cannabis Cannabinoid Res. 2022 Oct;7(5):706-716. doi: 10.1089/can.2021.0058. Epub 2021 Sep 27.

    PubMed 34569849

Questions about this trial

What is this clinical trial studying?

A study testing Cannabigerol in people with Health, Subjective and Inflammatory Response, run by Formula30A LLC at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Medical Symptom Questionnaire (MSQ) Score at 8 weeks (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05743985, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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