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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body processes and responds to cannabigerol (CBG), a chemical from the cannabis plant, when taken orally. The goal is to understand its effects and safety in healthy adults. Participants will receive varying doses of CBG or a placebo and will be monitored for any changes. Individuals who haven't recently used cannabis or other drugs and are in overall good health might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that reliable information about the safety of CBG (cannabigerol) when taken orally is lacking. This uncertainty extends to potential side effects. Some studies suggest that CBG could affect bacteria, but this provides little insight into its safety for humans. This trial represents an initial step in determining how well people tolerate CBG and its effects at different doses. As an early trial, it primarily focuses on understanding how the body processes CBG and its safety at various doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CHI-914 because it uses cannabigerol (CBG), a compound found in cannabis plants, which is being explored for its potential benefits. Unlike traditional treatments that often utilize THC or CBD, CBG is thought to have unique properties that might offer new therapeutic effects. Additionally, the study investigates varying doses, ranging from 25mg to 200mg, allowing researchers to better understand the dose-response relationship. This could lead to more personalized treatments and provide insights into the optimal dosage for health benefits without psychoactive effects.

What evidence suggests that CHI-914 might be an effective treatment for healthy participants?

Research has shown that cannabigerol (CBG) might help reduce anxiety and stress. One study found that people who took 20 mg of CBG felt significantly less anxious than those who took a placebo. Additionally, a survey revealed that 80% of CBG users believed it worked better for them than other options. Furthermore, 86.4% of users reported that CBG was more effective for inflammation than standard treatments. These findings suggest that CBG could address several health issues, but more research is needed for confirmation. This trial will explore the effects of different CBG dosages—25mg, 50mg, 100mg, and 200mg—compared to a placebo. ^{6 7 8 9 10}

Who Is on the Research Team?

Cecilia Bergeria, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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) 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05743985

Efficacy and Safety of Hemp-derived, Full Spectrum ... 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 ...

2. nature.com nature.com/articles/s41598-024-66879-0

Acute effects of cannabigerol on anxiety, stress, and mood Our prior survey study showed that over 30% of CBG users were self-medicating for depression and 80% reported CBG is more effective than ...

3. news.wsu.edu news.wsu.edu/press-release/2024/07/31/cannabinoid-cbg-reduces-anxiety-and-stress-in-first-human-clinical-trial/

Cannabinoid CBG reduces anxiety and stress in first human ... The research revealed that 20 mg of hemp-derived CBG significantly reduced feelings of anxiety at 20, 45 and 60 minutes after ingestion compared to a placebo.

4. withpower.com withpower.com/trial/cbg-effects-in-healthy-participants-5bae6

CBG Effects in Healthy Participants 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, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9587780/

Survey of Patients Employing Cannabigerol-Predominant ... Around 18.1% of responders endorsed CBG-predominant cannabis for “other inflammation,” with 86.4% reporting greater efficacy of CBG over conventional ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11597810/

Cannabigerol (CBG): A Comprehensive Review of Its ... Current studies revealed that CBG may disrupt the bacterial cell membrane, a crucial barrier to survival. This disruption can lead to the ...

7. dl.novachem.com.au dl.novachem.com.au/sds/assets/novachem.sds.C-141.pdf

Cannabigerol (CBG) - Novachem There is strong evidence to suggest that this material can cause, if inhaled once, very serious, irreversible damage of organs. The material is ...

8. web-resources-prod.zeptometrix.com web-resources-prod.zeptometrix.com/documents/public/SDS/SDSS-10246.pdf

Safety Data Sheet · Other adverse effects No further relevant information available. 13 Disposal considerations. · Waste treatment methods. · Recommendation: Must not be ...

9. webmd.com webmd.com/vitamins/ai/ingredientmono-1602/cannabigerol-cbg

Cannabigerol (Cbg) - Uses, Side Effects, and More When taken by mouth: There isn't enough reliable information to know if cannabigerol is safe or what the side effects might be. Pregnancy and breast-feeding: ...

10. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/36975m.pdf

Safety Data Sheet Very toxic for aquatic organisms. · Results of PBT and vPvB assessment. · PBT: Not applicable. · vPvB: Not applicable. · Other adverse effects ...