Cannabidiol PharmacokineticsPhase 1NCT03164512
The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol
A Phase 1 study testing Oral or vaporized cannabidiol in people with Cannabidiol Pharmacokinetics, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol administered via inhalation and oral ingestion. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabidiol Pharmacokinetics
- What is being tested?
- Oral or vaporized cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 22 Jan 2020
- 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 45 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 45
- 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 (confirmed by GC/MS laboratory test) and again upon admission for each experimental session
- Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session
- Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
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- 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.
- Have a body mass index (BMI) in the range of 19 to 36 kg/m2
- Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
- 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
- Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
- Report prior experience inhaling cannabis (either via smoking or vaporization).
Who cannot join
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month 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.
- Use of an OTC, 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.
- Use of hemp seeds or hemp oil in any form in the past 3 months.
- Use of dronabinol (Marinol) within the past 6 months.
- History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol administered via inhalation and oral ingestion.
Read the detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU) and the Johns Hopkins Bayview Clinical Research Unit (CRU). Participants will complete 4 acute drug administration periods, each consisting of a single drug exposure followed by a 5-day observation period (3-days (58-hours) inpatient and 2-days outpatient). Biological specimens will be obtained to characterize the pharmacokinetics of THC, CBD, and their metabolites in whole blood, oral fluid, urine, and hair during this period. Each participant will receive all 4 dose conditions in a counterbalanced order using a placebo controlled within-subject crossover design. The 4 drug conditions are as follows:
- Condition 1: Inhalation of cannabis vapor containing approximately a 20:1 ratio of CBD:THC and will be measured to deliver a target dose of 100mg CBD and 5mg THC.
- Condition 2: Inhalation of 100mg CBD vapor.
- Condition 3: Ingestion of 100mg CBD.
- Condition 4: Placebo
Drug administration will be double blind and double dummy; both inhalation and oral ingestion of study drugs will occur during all 4 sessions. The order of drug administration will be counterbalanced across participants.
Research volunteers will be recruited until up to 18 participants have completed each of the four study sessions (received Conditions 1-4). Immediately before (baseline) and following each exposure, a battery of assessments including biological fluid collection and testing, subjective questionnaire administration, and performance testing will be conducted for all study participants. Post-exposure testing will be conducted in two phases: a 3-day (58 hour) residential stay, and a 2-day outpatient period, for a total of 5 days. Participants who drop out of the study prior to completion of all 4 drug conditions will be considered "incomplete" and replaced. Approximately one week (minimum of 6 days) will separate the administration of each dose.
The target demographic for study participation are healthy adults who: 1) have a history of intentionally inhaling cannabis/CBD, 2) have not used cannabis in the past month (desire is to have participants free of cannabinoids in biological matrices at the time of initial drug administration), and 3) who are not currently dependent on or seeking treatment for use of cannabis or other psychoactive drugs.
Study outcome variables include quantitative levels of CBD and its primary metabolites, THC and its primary metabolites, results of drug testing procedures conducted in accordance with current federal Mandatory Guidelines for workplace drug testing, subjective drug effect ratings, and performance on behavioral assessments. Biological specimens will be analyzed by an independent laboratory with validated analytical procedures that are specific and accurate for measurement of marijuana constituents and related metabolites. Subjective, cardiovascular and behavioral outcomes will be assessed using multiple regression analyses appropriate for repeated measures testing based on the final characteristics of the data set (e.g. normal distribution, skewness, kurtosis), and correlated with biomarker results of interest.
- Conditions
- Cannabidiol Pharmacokinetics
- Being tested
- Oral or vaporized cannabidiol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral or vaporized cannabidiolDrug
Acute drug exposure
PlaceboDrug
Placebo capsule/vapor
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo oral and vapor Receives: Drug: Placebo |
| Vaporized High Cannabidiol Cannabis | Experimental | Cannabis containing approximately 100mg cannabidiol and 5mg delta-9-THC Receives: Drug: Oral or vaporized cannabidiol |
| Vaporized Cannabidiol | Experimental | 100mg cannabidiol in vapor Receives: Drug: Oral or vaporized cannabidiol |
| Oral Cannabidiol | Experimental | 100mg oral cannabidiol Receives: Drug: Oral or vaporized cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
THC-COOH in Urine
THC-COOH in Urine
Measured: Hour 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jun 2018
- Primary completion29 Aug 2019
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabidiol PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Vandrey, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164512
- Sponsor's protocol ID
- IRB00128331
- Status last verified
- Jan 2020
- First submitted
- 22 May 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual biological testing data will be published. Requests for additional data can be submitted to Dr. Vandrey via e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol
- ClinicalTrials.gov ID
- NCT03164512
- Acronym / sponsor ID
- IRB00128331
- Conditions
- Cannabidiol Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 23 May 2017 (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.
This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol administered via inhalation and oral ingestion.
Detailed description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU) and the Johns Hopkins Bayview Clinical Research Unit (CRU). Participants will complete 4 acute drug administration periods, each consisting of a single drug exposure followed by a 5-day observation period (3-days (58-hours) inpatient and 2-days outpatient). Biological specimens will be obtained to characterize the pharmacokinetics of THC, CBD, and their metabolites in whole blood, oral fluid, urine, and hair during this period. Each participant will receive all 4 dose conditions in a counterbalanced order using a placebo controlled within-subject crossover design. The 4 drug conditions are as follows:
- Condition 1: Inhalation of cannabis vapor containing approximately a 20:1 ratio of CBD:THC and will be measured to deliver a target dose of 100mg CBD and 5mg THC.
- Condition 2: Inhalation of 100mg CBD vapor.
- Condition 3: Ingestion of 100mg CBD.
- Condition 4: Placebo
Drug administration will be double blind and double dummy; both inhalation and oral ingestion of study drugs will occur during all 4 sessions. The order of drug administration will be counterbalanced across participants.
Research volunteers will be recruited until up to 18 participants have completed each of the four study sessions (received Conditions 1-4). Immediately before (baseline) and following each exposure, a battery of assessments including biological fluid collection and testing, subjective questionnaire administration, and performance testing will be conducted for all study participants. Post-exposure testing will be conducted in two phases: a 3-day (58 hour) residential stay, and a 2-day outpatient period, for a total of 5 days. Participants who drop out of the study prior to completion of all 4 drug conditions will be considered "incomplete" and replaced. Approximately one week (minimum of 6 days) will separate the administration of each dose.
The target demographic for study participation are healthy adults who: 1) have a history of intentionally inhaling cannabis/CBD, 2) have not used cannabis in the past month (desire is to have participants free of cannabinoids in biological matrices at the time of initial drug administration), and 3) who are not currently dependent on or seeking treatment for use of cannabis or other psychoactive drugs.
Study outcome variables include quantitative levels of CBD and its primary metabolites, THC and its primary metabolites, results of drug testing procedures conducted in accordance with current federal Mandatory Guidelines for workplace drug testing, subjective drug effect ratings, and performance on behavioral assessments. Biological specimens will be analyzed by an independent laboratory with validated analytical procedures that are specific and accurate for measurement of marijuana constituents and related metabolites. Subjective, cardiovascular and behavioral outcomes will be assessed using multiple regression analyses appropriate for repeated measures testing based on the final characteristics of the data set (e.g. normal distribution, skewness, kurtosis), and correlated with biomarker results of interest.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral and vapor |
| Vaporized High Cannabidiol Cannabis | Experimental | Drug: Oral or vaporized cannabidiolCannabis containing approximately 100mg cannabidiol and 5mg delta-9-THC |
| Vaporized Cannabidiol | Experimental | Drug: Oral or vaporized cannabidiol100mg cannabidiol in vapor |
| Oral Cannabidiol | Experimental | Drug: Oral or vaporized cannabidiol100mg oral cannabidiol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Have provided written informed consent
- Be between the ages of 18 and 45
- 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 (confirmed by GC/MS laboratory test) and again upon admission for each experimental session
- Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session
Key exclusion criteria (8 listed)
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month 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.
- Use of an OTC, 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.
- Use of hemp seeds or hemp oil in any form in the past 3 months.
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 or vaporized cannabidiolAcute drug exposure | Drug | Oral Cannabidiol, Vaporized Cannabidiol, Vaporized High Cannabidiol Cannabis |
| PlaceboPlacebo capsule/vapor | Drug | Placebo |
Primary outcome
THC-COOH in Urine
Time frame: Hour 4
THC-COOH in Urine
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 Jan 2020.
- Individual participant dataSharing planned: Yes. Individual biological testing data will be published. Requests for additional data can be submitted to Dr. Vandrey via e-mail.
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.
Ryan Vandrey, 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 or vaporized cannabidiol in people with Cannabidiol Pharmacokinetics, run by Johns Hopkins University 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 12 inclusion and 8 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 Jan 2020. 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?
THC-COOH in Urine (time frame: Hour 4). 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 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.