CannabisPhase 1NCT03676166
Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis
A Phase 1 study testing Cannabis in people with Cannabis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of smoked and vaporized cannabis. Careful analysis of different cannabis administration methods on these parameters is required to determine the level and duration of biological cannabinoid exposure and associated subjective… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2016to 17 Jan 2017
- 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, 12-lead ECG 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 at clinic admission
- Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
- 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
- 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
Who cannot join
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 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.
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- 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).
- Abnormal EKG result that in the investigator's opinion is clinically significant.
- 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 School of Medicine Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of smoked and vaporized cannabis. Careful analysis of different cannabis administration methods on these parameters is required to determine the level and duration of biological cannabinoid exposure and associated subjective, cardiovascular and cognitive effects. In the present study the investigators evaluated the detection of cannabinoids in whole blood, oral fluid, and urine, as well as the acute pharmacodynamics associated with smoked and vaporized cannabis among individuals who were not regular cannabis users. The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of smoked and vaporized cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.
- Conditions
- Cannabis
- Being tested
- Cannabis
- Keywords
- Cannabis, Toxicology, Intoxication
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Inhaled cannabis
| Study group | Role | What they receive |
|---|---|---|
| 0mg THC smoked cannabis | Experimental | placebo smoked cannabis Receives: Drug: Cannabis |
| 10mg THC smoked cannabis | Experimental | smoked cannabis containing 10mg THC Receives: Drug: Cannabis |
| 25mg THC smoked cannabis | Experimental | smoked cannabis containing 25mg THC Receives: Drug: Cannabis |
| 0mg THC vaporized cannabis | Experimental | placebo vaporized cannabis Receives: Drug: Cannabis |
| 10mg THC vaporized cannabis | Experimental | vaporized cannabis containing 10mg THC Receives: Drug: Cannabis |
| 25mg THC vaporized cannabis | Experimental | vaporized cannabis containing 25mg THC Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of THC in blood
Quantitative measurement of blood THC by LC-MS/MS
Measured: 8 hours post exposure
Secondary outcomes (4)
Subjective rating of "Drug Effect"
Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: 8 hours post exposure
Psychomotor performance as assessed by Digit Symbol Substitution Task
Computerized version of Digit Symbol Substitution Task administered, total correct trials in 90-seconds measured
Measured: 8 hours post exposure
Memory performance as assessed by Paced Auditory Serial Addition Task
Computerized version of Paced Auditory Serial Addition Task administered, total correct trials out of 90 recorded
Measured: 8 hours post exposure
Performance on Divided Attention Task
Computerized Divided Attention Task administered, mean distance from central stimulus and number of targets correct out of 24 recorded
Measured: 8 hours post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start16 Jun 2016
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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, Investigator
- Enrolment
- 18 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 School of Medicine Behavioral Pharmacology Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676166
- Sponsor's protocol ID
- IRB_00035394
- Status last verified
- Sep 2018
- First submitted
- 16 Sep 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Spindle TR, Cone EJ, Schlienz NJ, Mitchell JM, Bigelow GE, Flegel R, Hayes E, Vandrey R. Acute Effects of Smoked and Vaporized Cannabis in Healthy Adults Who Infrequently Use Cannabis: A Crossover Trial. JAMA Netw Open. 2018 Nov 2;1(7):e184841. doi: 10.1001/jamanetworkopen.2018.4841.
PubMed 30646391
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis
- ClinicalTrials.gov ID
- NCT03676166
- Acronym / sponsor ID
- IRB_00035394
- Conditions
- Cannabis
- Keywords
- Cannabis, Toxicology, Intoxication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 18 Sep 2018 (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.
Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of smoked and vaporized cannabis. Careful analysis of different cannabis administration methods on these parameters is required to determine the level and duration of biological cannabinoid exposure and associated subjective, cardiovascular and cognitive effects. In the present study the investigators evaluated the detection of cannabinoids in whole blood, oral fluid, and urine, as well as the acute pharmacodynamics associated with smoked and vaporized cannabis among individuals who were not regular cannabis users. The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of smoked and vaporized cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0mg THC smoked cannabis | Experimental | Drug: Cannabisplacebo smoked cannabis |
| 10mg THC smoked cannabis | Experimental | Drug: Cannabissmoked cannabis containing 10mg THC |
| 25mg THC smoked cannabis | Experimental | Drug: Cannabissmoked cannabis containing 25mg THC |
| 0mg THC vaporized cannabis | Experimental | Drug: Cannabisplacebo vaporized cannabis |
| 10mg THC vaporized cannabis | Experimental | Drug: Cannabisvaporized cannabis containing 10mg THC |
| 25mg THC vaporized cannabis | Experimental | Drug: Cannabisvaporized cannabis containing 25mg THC |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 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, 12-lead ECG 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 at clinic admission
- Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
Key exclusion criteria (10 listed)
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 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 |
|---|---|---|
| CannabisInhaled cannabis | Drug | 0mg THC smoked cannabis, 0mg THC vaporized cannabis, 10mg THC smoked cannabis, 10mg THC vaporized cannabis, 25mg THC smoked cannabis, 25mg THC vaporized cannabis |
Primary outcome
Quantity of THC in blood
Time frame: 8 hours post exposure
Quantitative measurement of blood THC by LC-MS/MS
4 secondary outcomes
Subjective rating of "Drug Effect"
Time frame: 8 hours post exposure
Psychomotor performance as assessed by Digit Symbol Substitution Task
Time frame: 8 hours post exposure
Memory performance as assessed by Paced Auditory Serial Addition Task
Time frame: 8 hours post exposure
Performance on Divided Attention Task
Time frame: 8 hours post exposure
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 13 Sep 2019.
- Derived from this study: PubMed 30646391Spindle TR, Cone EJ, Schlienz NJ, Mitchell JM, Bigelow GE, Flegel R, Hayes E, Vandrey R. Acute Effects of Smoked and Vaporized Cannabis in Healthy Adults Who Infrequently Use Cannabis: A Crossover Trial. JAMA Netw Open. 2018 Nov 2;1(7):e184841. doi: 10.1001/jamanetworkopen.2018.4841.
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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 School of Medicine Behavioral Pharmacology Research Unit
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 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 8 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 13 Sep 2019. 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. 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?
Quantity of THC in blood (time frame: 8 hours post exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676166, which also lists 1 linked publication.
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 13 Sep 2019.