CBG Effects in Healthy Participants

Overseen By Cecilia Bergeria, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Psychoactive drugs, Prescription medications

Disqualifiers: Significant illness, Cardiac arrhythmias, Seizures, others

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

30 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking any prescription medications (except birth control) and over-the-counter drugs, herbal supplements, or vitamins at least 14 days before the experimental sessions, as they might interfere with the study results or your safety.

What data supports the effectiveness of the drug CHI-914, Cannabigerol (CBG), in healthy participants?

Research suggests that Cannabigerol (CBG) may help with anxiety, chronic pain, depression, and sleep issues, with many users reporting it works better than traditional medicines for these conditions. CBG also shows potential for reducing inflammation and protecting nerves, making it a promising compound for various health issues. ^{1 2 3 4 5}

Is cannabigerol (CBG) safe for human use?

Cannabigerol (CBG) appears to be generally safe for human use, with a study showing that 44% of users reported no adverse effects. Some users experienced mild side effects like dry mouth, sleepiness, and increased appetite, but withdrawal symptoms were rare. ^{1 2 3 5 6}

How is the drug CHI-914 (Cannabigerol, CBG) unique compared to other treatments?

CHI-914, or Cannabigerol (CBG), is unique because it is a non-psychoactive cannabinoid from the Cannabis plant that interacts with various receptors, potentially offering benefits like reducing anxiety, pain, and inflammation without the high associated with THC. Unlike many conventional treatments, CBG is reported to have a favorable safety profile with minimal side effects and withdrawal symptoms. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of cannabigerol (CBG; CHI-914), a naturally occurring chemical constituent of the cannabis plant formulated for oral consumption, in healthy adults. The study will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design.Upon enrollment, participants will complete 5 oral dosing conditions (placebo, 25, 50, 100, and 200 mg CBG). Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic drug effects. This work will provide novel data on the pharmacokinetics, pharmacodynamic effects, and safety of acute oral CBG dose administration in humans.

Research Team

Cecilia Bergeria, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for healthy adults aged 18-55 with a BMI of 18-30 kg/m2, who have used cannabis before but not in the last 30 days. Participants must test negative for drugs and pregnancy, be non-pregnant, non-nursing if female, and not have donated blood recently. Those with heart issues, drug abuse history, or on certain medications are excluded.

Inclusion Criteria

Have not donated blood in the prior 30 days

Test negative for recent cannabis use in urine at the screening visit and again upon admission for the experimental sessions

Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission

Exclusion Criteria

Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing

Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk

I am not using, or unwilling to use, birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 5 oral dosing conditions (placebo, 25, 50, 100, and 200 mg CBG) with each condition consisting of a single acute drug exposure followed by an 8-hour evaluation period

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CHI-914

Trial Overview The study tests how different doses of oral CBG (a cannabis component) affect the body compared to a placebo. Healthy participants will try five dosing conditions in a controlled environment to assess CBG's effects and safety over an eight-hour period after each dose.

Participant Groups

Group I: Oral administration of 50mg CBG Experimental Treatment 1 Intervention

Single acute administration of 50mg CBG suspended in MCT oil.

Group II: Oral administration of 25mg CBG Experimental Treatment 1 Intervention

Single acute administration of 25mg CBG suspended in MCT oil.

Group III: Oral administration of 200mg CBG Experimental Treatment 1 Intervention

Single acute administration of 200mg CBG suspended in MCT oil.

Group IV: Oral administration of 100mg CBG Experimental Treatment 1 Intervention

Single acute administration of 100mg CBG suspended in MCT oil.

Group V: Placebo Placebo Group 1 Intervention

Single acute administration of oral Placebo liquid (MCT oil).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Canopy Growth Corporation

Industry Sponsor

Trials

15

Recruited

1,200+

Findings from Research

Cannabigerol (CBG) is a non-psychoactive cannabinoid that shows promise for various therapeutic applications, including reducing intraocular pressure and exhibiting anti-inflammatory and anti-tumoral effects, based on pre-clinical studies.

CBG acts as a partial agonist at cannabinoid receptors and interacts with other receptors, suggesting it could be a valuable component in developing treatments for conditions like anxiety and neuroprotection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Aspects and Biological Effects of Cannabigerol and Its Synthetic Derivatives. Calapai, F., Cardia, L., Esposito, E., et al.[2022]

A survey of 127 CBG-predominant cannabis users revealed that most use it for medical purposes, particularly for treating anxiety, chronic pain, depression, and insomnia, with many reporting significant improvements in their conditions.

The study found a favorable safety profile for CBG, with 44% of users reporting no adverse effects and only a small percentage experiencing mild symptoms, suggesting that CBG-predominant cannabis may be a viable alternative to conventional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. Russo, EB., Cuttler, C., Cooper, ZD., et al.[2023]

Cannabigerol (CBG) shows potential therapeutic benefits for neurological disorders and inflammatory bowel disease, with unique interactions at cannabinoid receptors and other receptors like α-2 adrenoceptors and 5-HT1A.

Despite its promising effects, CBG is largely unregulated and under-researched compared to other cannabinoids like CBD, highlighting the need for further studies to understand its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pharmacological Case for Cannabigerol. Nachnani, R., Raup-Konsavage, WM., Vrana, KE.[2021]

Cannabigerol (CBG) effectively reduces mechanical hypersensitivity in mice with cisplatin-induced peripheral neuropathy, suggesting its potential as a treatment for neuropathic pain.

The anti-nociceptive effects of CBG are mediated through specific receptors, as its efficacy was blocked by α2-adrenergic and CB1/CB2 receptor antagonists, but not by TRPV1 antagonists, indicating a targeted mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabigerol (CBG) attenuates mechanical hypersensitivity elicited by chemotherapy-induced peripheral neuropathy. Sepulveda, DE., Morris, DP., Raup-Konsavage, WM., et al.[2022]

Cannabigerol (CBG), a compound derived from Cannabis sativa L., shows promising therapeutic potential due to its wide range of biological activities, including anti-inflammatory, antibacterial, and neuromodulatory effects.

CBG's ability to interact with G-protein-coupled receptors suggests it could be useful in treating various diseases that require complex pharmacotherapy, making it a candidate for future therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Origin and Biomedical Relevance of Cannabigerol. Jastrząb, A., Jarocka-Karpowicz, I., Skrzydlewska, E.[2022]

Cannabigerol (CBG) and cannabidivarin (CBDV) demonstrated protective effects against ischemic stroke in human brain microvascular endothelial cells, pericytes, and astrocytes, by reducing harmful cytokines and cell damage markers after oxygen-glucose deprivation.

CBG decreased DNA damage markers in astrocytes, while CBDV showed a complex profile by reducing certain inflammatory factors but increasing others, indicating different mechanisms of action that warrant further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective Effects of Cannabidivarin and Cannabigerol on Cells of the Blood-Brain Barrier Under Ischemic Conditions. Stone, NL., England, TJ., O'Sullivan, SE.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pharmacological Aspects and Biological Effects of Cannabigerol and Its Synthetic Derivatives. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Survey of Patients Employing Cannabigerol-Predominant Cannabis Preparations: Perceived Medical Effects, Adverse Events, and Withdrawal Symptoms. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Pharmacological Case for Cannabigerol. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Cannabigerol (CBG) attenuates mechanical hypersensitivity elicited by chemotherapy-induced peripheral neuropathy. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Origin and Biomedical Relevance of Cannabigerol. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Protective Effects of Cannabidivarin and Cannabigerol on Cells of the Blood-Brain Barrier Under Ischemic Conditions. [2021]