INTERVENTIONALCOMPLETEDNCT05324982

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-07-27

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1
Enrollment: 12 (ACTUAL)
Start date: 2022-08-09
Sponsor: University of Maryland, Baltimore
Design: RANDOMIZED · CROSSOVER · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

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. Oral drug administration will be double blind (the participant and research staff will be unaware of the dose administered; though active doses will be fixed in ascending order, placebo will be randomly assigned). Upon enrollment, participants will complete 5 oral dosing conditions (placebo, 25, 50, 100, and 200 mg CBG). Doses were selected based on current retail CBG products and web-based surveys of CBG use among current CBG product users. Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic drug effects. Blood specimens will be obtained throughout these 8 hours to characterize the pharmacokinetics of CBG. Pharmacodynamic assessments including subjective drug effects, cognitive performance testing, and vital signs will also be collected for 8 hours post-drug administration. Experimental test sessions will be separated by at least 1 week to allow for sufficient drug washout between doses. This work will provide novel data on the pharmacokinetics, pharmacodynamic effects, and safety of acute oral CBG dose administration in humans.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

cannabigerol

Medicines

Population and criteria

Sex

ALL

Minimum age

18 Years

Maximum age

55 Years

Healthy volunteers

Accepted

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.

primary measures

Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)

Time frame: 8 hours

Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

Heart rate

Time frame: 8 hours

Heart rate (beats/minute) will be measured while sitting down using the vitals machine.

Blood Pressure

Time frame: 8 hours

Blood pressure (mmHg) will be measured while sitting down using the vitals machine.

Divided Attention as assessed by the DAT

Time frame: 8 hours

Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.

Digit Symbol Substitution Task (DSST) score

Time frame: 8 hours

Digit Symbol Substitution Task, cognitive task administered to assess response speed, sustained attention, visual spatial skills and set shifting.

Paced Auditory Serial Addition Task (PASAT) score

Time frame: 8 hours

Paced Auditory Serial Addition Task, cognitive task that measures cognitive function by assessing auditory information processing speed and flexibility, as well as calculation ability.

Behavioral task performance as assessed by the DRUID app

Time frame: 8 hours

Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance.

Digit Vigilance Test (response time)

Time frame: 8 hours

Digit Vigilance Test, primary outcome is response time of all trials.

Digit Vigilance Test (number of incorrect responses)

Time frame: 8 hours

Digit Vigilance Test, primary outcome is number of incorrect responses of all trials.

Go/No-Go Task (response time)

Time frame: 8 hours

Go/No-Go Task, primary outcome is response time of all trials.

Go/No-Go Task (number of incorrect responses)

Time frame: 8 hours

Go/No-Go Task, primary outcome is number of incorrect responses of all trials.

Quantitative levels of CHI-914 (CBG) in blood

Time frame: 8 hours

Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).

Quantitative levels of CHI-914 (CBG) in urine

Time frame: 8 hours

Urine is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).

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

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Oral Placebo

Oral CBG Cannabis

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)

Heart rate

Blood Pressure

Divided Attention as assessed by the DAT

Digit Symbol Substitution Task (DSST) score

Paced Auditory Serial Addition Task (PASAT) score

Behavioral task performance as assessed by the DRUID app

Digit Vigilance Test (response time)

Digit Vigilance Test (number of incorrect responses)

Go/No-Go Task (response time)

Go/No-Go Task (number of incorrect responses)

Quantitative levels of CHI-914 (CBG) in blood

Quantitative levels of CHI-914 (CBG) in urine

Locally readable linked articles