Examining the effects of cannabigerol in healthy adults

A Randomized, Double-Blind, Placebo-Controlled Study, Pharmacokinetics, and Pharmacodynamics of CHI-914 in Healthy Participants

This study is testing how different doses of cannabigerol (CBG) affect healthy adults to see how it works in the body and mind.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05324982 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics and pharmacodynamics of cannabigerol (CBG), a compound derived from cannabis, in healthy adults. Participants will undergo a placebo-controlled, double-blind, ascending-dose design, where they will receive varying doses of CBG (25, 50, 100, and 200 mg) or a placebo. Each dosing condition will involve a single acute exposure followed by an 8-hour assessment period to evaluate the drug's effects on the body and mind. Blood samples will be collected to analyze how CBG is processed in the body, alongside cognitive performance tests and vital sign monitoring. The findings aim to provide new insights into the safety and effects of CBG when taken orally.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 55 who have prior experience with cannabis but have not used any cannabinoid products in the last 30 days.

Not a fit: Patients who are pregnant, nursing, or have recent cannabis use or other drug abuse issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of CBG's effects, potentially leading to new therapeutic applications for cannabis-derived compounds.

How similar studies have performed: While studies on cannabis compounds exist, this specific investigation into CBG's pharmacokinetics and pharmacodynamics is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Have provided written informed consent.
2. Be between the ages of 18 and 55.
3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests.
4. Test negative for recent cannabis use in urine at the screening visit and again upon admission for the experimental sessions.
5. Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session.
6. 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.
7. Have a body mass index (BMI) in the range of 18 to 30 kg/m2.
8. Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg.
9. Self-report prior experience using cannabis, but no use of any cannabinoid products in the prior 30 days.
10. Have not donated blood in the prior 30 days.

Exclusion Criteria:

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the 30-days prior to the Screening Visit.
2. History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
3. Endorse suicidal intent as indexed by endorsement of questions #4 and #5 on the C-SSRS.
4. Use of an over-the-counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
5. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
6. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
7. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
8. Epilepsy or a history of seizures.
9. Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.
10. Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception.

Where this trial is running

Baltimore, Maryland

• Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Cecilia Bergeria, PhD — Johns Hopkins University
• Study coordinator: Cecilia Bergeria, PhD

Conditions Behavioral Pharmacology of Cannabis