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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
30
Placebo will be orally self-administered by study participants.
CBG cannabis oil will be orally self-administered by study participants.
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
RECRUITINGSelf-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)
Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.
Time frame: 8 hours
Heart rate
Heart rate (beats/minute) will be measured while sitting down using the vitals machine.
Time frame: 8 hours
Blood Pressure
Blood pressure (mmHg) will be measured while sitting down using the vitals machine.
Time frame: 8 hours
Divided Attention as assessed by the DAT
Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.
Time frame: 8 hours
Digit Symbol Substitution Task (DSST) score
Digit Symbol Substitution Task, cognitive task administered to assess response speed, sustained attention, visual spatial skills and set shifting.
Time frame: 8 hours
Paced Auditory Serial Addition Task (PASAT) score
Paced Auditory Serial Addition Task, cognitive task that measures cognitive function by assessing auditory information processing speed and flexibility, as well as calculation ability.
Time frame: 8 hours
Behavioral task performance as assessed by the DRUID app
Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance.
Time frame: 8 hours
Digit Vigilance Test (response time)
Digit Vigilance Test, primary outcome is response time of all trials.
Time frame: 8 hours
Digit Vigilance Test (number of incorrect responses)
Digit Vigilance Test, primary outcome is number of incorrect responses of all trials.
Time frame: 8 hours
Go/No-Go Task (response time)
Go/No-Go Task, primary outcome is response time of all trials.
Time frame: 8 hours
Go/No-Go Task (number of incorrect responses)
Go/No-Go Task, primary outcome is number of incorrect responses of all trials.
Time frame: 8 hours
Quantitative levels of CHI-914 (CBG) in blood
Blood is collected through an intravenous catheter, quantitative results are reported in nanograms per milliliter (ng/ml).
Time frame: 8 hours
Quantitative levels of CHI-914 (CBG) in urine
Urine is provided by participant, quantitative results are reported in nanograms per milliliter (ng/ml).
Time frame: 8 hours
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