Behavioral Pharmacology of CannabisPhase 1NCT05324982
Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
A Phase 1 study testing Oral CBG Cannabis in people with Behavioral Pharmacology of Cannabis, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Pharmacology of Cannabis
- What is being tested?
- Oral CBG Cannabis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to 15 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have provided written informed consent.
- Be between the ages of 18 and 55.
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests.
- Test negative for recent cannabis use in urine at the screening visit and again upon admission for the experimental sessions.
- Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session.
- 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.
Show all 10Show fewer
- Have a body mass index (BMI) in the range of 18 to 30 kg/m2.
- 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.
- Self-report prior experience using cannabis, but no use of any cannabinoid products in the prior 30 days.
- Have not donated blood in the prior 30 days.
Who cannot join
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the 30-days prior to the Screening Visit.
- 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.
- Endorse suicidal intent as indexed by endorsement of questions #4 and #5 on the C-SSRS.
- 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.
- 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.
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Show all 10Show fewer
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
- Epilepsy or a history of seizures.
- Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study, Pharmacokinetics, and Pharmacodynamics of CHI-914 in Healthy Participants
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.
Read the detailed description
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.
- Conditions
- Behavioral Pharmacology of Cannabis
- Being tested
- Oral Placebo, Oral CBG Cannabis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral PlaceboDrug
Placebo will be orally self-administered by study participants.
Oral CBG CannabisDrug
Also called marijuana
CBG cannabis oil will be orally self-administered by study participants.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single acute administration of oral Placebo liquid (MCT oil). Receives: Drug: Oral Placebo |
| Oral administration of 25mg CBG | Experimental | Single acute administration of 25mg CBG suspended in MCT oil. Receives: Drug: Oral CBG Cannabis |
| Oral administration of 50mg CBG | Experimental | Single acute administration of 50mg CBG suspended in MCT oil. Receives: Drug: Oral CBG Cannabis |
| Oral administration of 100mg CBG | Experimental | Single acute administration of 100mg CBG suspended in MCT oil. Receives: Drug: Oral CBG Cannabis |
| Oral administration of 200mg CBG | Experimental | Single acute administration of 200mg CBG suspended in MCT oil. Receives: Drug: Oral CBG Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-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.
Measured: 8 hours
Heart rate
Heart rate (beats/minute) will be measured while sitting down using the vitals machine.
Measured: 8 hours
Blood Pressure
Blood pressure (mmHg) will be measured while sitting down using the vitals machine.
Measured: 8 hours
Divided Attention as assessed by the DAT
Divided Attention Task (DAT), cognitive task administered on the computer to assess divided attention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 hours
Digit Vigilance Test (response time)
Digit Vigilance Test, primary outcome is response time of all trials.
Measured: 8 hours
Digit Vigilance Test (number of incorrect responses)
Digit Vigilance Test, primary outcome is number of incorrect responses of all trials.
Measured: 8 hours
Go/No-Go Task (response time)
Go/No-Go Task, primary outcome is response time of all trials.
Measured: 8 hours
Go/No-Go Task (number of incorrect responses)
Go/No-Go Task, primary outcome is number of incorrect responses of all trials.
Measured: 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).
Measured: 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).
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start9 Aug 2022
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Pharmacology of CannabisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A within-subjects design.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Canopy Growth Corporation, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Cecilia Bergeria, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324982
- Sponsor's protocol ID
- IRB00307925
- Status last verified
- Jul 2026
- First submitted
- 5 Apr 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study, Pharmacokinetics, and Pharmacodynamics of CHI-914 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05324982
- Acronym / sponsor ID
- IRB00307925
- Conditions
- Behavioral Pharmacology of Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Canopy Growth Corporation, Johns Hopkins University
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- A within-subjects design.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Oral PlaceboSingle acute administration of oral Placebo liquid (MCT oil). |
| Oral administration of 25mg CBG | Experimental | Drug: Oral CBG CannabisSingle acute administration of 25mg CBG suspended in MCT oil. |
| Oral administration of 50mg CBG | Experimental | Drug: Oral CBG CannabisSingle acute administration of 50mg CBG suspended in MCT oil. |
| Oral administration of 100mg CBG | Experimental | Drug: Oral CBG CannabisSingle acute administration of 100mg CBG suspended in MCT oil. |
| Oral administration of 200mg CBG | Experimental | Drug: Oral CBG CannabisSingle acute administration of 200mg CBG suspended in MCT oil. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Have provided written informed consent.
- Be between the ages of 18 and 55.
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests.
- Test negative for recent cannabis use in urine at the screening visit and again upon admission for the experimental sessions.
- Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session.
Key exclusion criteria (10 listed)
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the 30-days prior to the Screening Visit.
- 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.
- Endorse suicidal intent as indexed by endorsement of questions #4 and #5 on the C-SSRS.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral PlaceboPlacebo will be orally self-administered by study participants. | Drug | Placebo |
| Oral CBG CannabisAlso: marijuanaCBG cannabis oil will be orally self-administered by study participants. | Drug | Oral administration of 100mg CBG, Oral administration of 200mg CBG, Oral administration of 25mg CBG, Oral administration of 50mg CBG |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Behavioral Pharmacology of Cannabis
Not yet recruitingPhase 1
Behavioral Pharmacology of THC and Beta-Myrcene
Cannabis Use
RecruitingPhase 2
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
THC, Cannabis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Bergeria, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral CBG Cannabis in people with Behavioral Pharmacology of Cannabis, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ) (time frame: 8 hours). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.