Behavioral Pharmacology of CannabisPhase 1NCT03122691
Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
A Phase 1 study testing cannabis in people with Behavioral Pharmacology of Cannabis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Pharmacology of Cannabis
- What is being tested?
- cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Feb 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
- Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
- Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
- Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
- 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
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- 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
- 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 Over-the-Counter (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.
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- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Abnormal EKG result that in the investigator's opinion is clinically significant.
- Epilepsy or a history of seizures.
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
About this study
This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.
- Conditions
- Behavioral Pharmacology of Cannabis
- Being tested
- cannabis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannabisDrug
Also called marijuana
Cannabis will be self-administered by study participants
| Study group | Role | What they receive |
|---|---|---|
| Placebo Oral Cannabis | Placebo comparator | Single acute administration of placebo cannabis baked into a brownie Receives: Drug: cannabis |
| Low-Dose Oral Cannabis | Experimental | Single acute administration of cannabis containing 10mg THC baked into a brownie Receives: Drug: cannabis |
| High-Dose Oral Cannabis | Experimental | Single acute administration of cannabis containing 25mg THC baked into a brownie Receives: Drug: cannabis |
| Placebo Vaporized Cannabis | Placebo comparator | Single acute administration of placebo cannabis via commercial vaporizer Receives: Drug: cannabis |
| Low-Dose Vaporized Cannabis | Experimental | Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer Receives: Drug: cannabis |
| High-Dose Vaporized Cannabis | Experimental | Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer Receives: Drug: cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetrahydrocannabinol (THC) Concentration in Blood
Quantitation of active drug (THC) in whole blood (ng/ml).
Measured: 8 hours
Secondary outcomes (6)
11-hydroxy-tetrahydrocannabinol (11-OH-THC)
Quantitation of THC metabolite in blood (ng/ml)
Measured: 8 hours
Tetrahydrocannabinolic Acid (THCCOOH)
Quantitation of THC metabolite in blood (ng/ml).
Measured: 8 hours
Change in Heart Rate
Peak change from baseline
Measured: Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure
Mean (SD) Peak Change-from-baseline Drug Effect Rating
Subjective rating of drug effect (0-100) at peak effect: between 2 and 5 hours for oral dosing conditions and 0 and 2 hours for vaporized conditions. Higher numbers mean stronger drug effects, where 0 means no drug effect and 100 means extremely strong drug effect.
Measured: Up to 5 hours
Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score
Composite Global Impairment Score on the DRUID (DRiving Under the Influence of Drugs) App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance. ≥13-point change (from baseline) on DRUID global impairment score = "impaired"; <13-point change (from baseline) = "not impaired".
Measured: 8 hours
Peak Change in Blood Pressure
Systolic and Diastolic blood pressure will be measured at baseline and repeatedly for 8 hours after drug exposure. Outcome is the peak change from baseline assessed within the 8 hour period of assessment.
Measured: 8 hours post drug exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 May 2018
- Primary completion11 Jun 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Behavioral Pharmacology of CannabisStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, U.S. Department of Justice, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ryan Vandrey, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122691
- Sponsor's protocol ID
- IRB00122849
- Other IDs
- 2016-DN-BX-0193, R44DA046272-01A1, T32DA007209
- Status last verified
- Jan 2023
- First submitted
- 17 Apr 2017
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
- ClinicalTrials.gov ID
- NCT03122691
- Acronym / sponsor ID
- IRB00122849
- Conditions
- Behavioral Pharmacology of Cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- RTI International, U.S. Department of Justice, National Institute on Drug Abuse (NIDA)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo Oral Cannabis | Placebo comparator | Drug: cannabisSingle acute administration of placebo cannabis baked into a brownie |
| Low-Dose Oral Cannabis | Experimental | Drug: cannabisSingle acute administration of cannabis containing 10mg THC baked into a brownie |
| High-Dose Oral Cannabis | Experimental | Drug: cannabisSingle acute administration of cannabis containing 25mg THC baked into a brownie |
| Placebo Vaporized Cannabis | Placebo comparator | Drug: cannabisSingle acute administration of placebo cannabis via commercial vaporizer |
| Low-Dose Vaporized Cannabis | Experimental | Drug: cannabisSingle acute administration of placebo cannabis containing 5mg THC via commercial vaporizer |
| High-Dose Vaporized Cannabis | Experimental | Drug: cannabisSingle acute administration of placebo cannabis containing 20mg THC via commercial vaporizer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
- Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
- Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
- Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
- 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.
Key exclusion criteria (10 listed)
- 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 Over-the-Counter (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.
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 |
|---|---|---|
| cannabisAlso: marijuanaCannabis will be self-administered by study participants | Drug | High-Dose Oral Cannabis, High-Dose Vaporized Cannabis, Low-Dose Oral Cannabis, Low-Dose Vaporized Cannabis, Placebo Oral Cannabis, Placebo Vaporized Cannabis |
Primary outcome
Tetrahydrocannabinol (THC) Concentration in Blood
Time frame: 8 hours
Quantitation of active drug (THC) in whole blood (ng/ml).
6 secondary outcomes
11-hydroxy-tetrahydrocannabinol (11-OH-THC)
Time frame: 8 hours
Tetrahydrocannabinolic Acid (THCCOOH)
Time frame: 8 hours
Change in Heart Rate
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure
Mean (SD) Peak Change-from-baseline Drug Effect Rating
Time frame: Up to 5 hours
Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score
Time frame: 8 hours
Peak Change in Blood Pressure
Time frame: 8 hours post drug exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 cannabis in people with Behavioral Pharmacology of Cannabis, 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 9 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 21 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tetrahydrocannabinol (THC) Concentration in Blood (time frame: 8 hours). 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 21 Feb 2023.