CannabisPhase 1NCT02165176
Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis
A Phase 1 study testing Oral 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 orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of oral cannabis dose effects on these parameters is required to determine the level and duration of biological cannabinoid exposure and… 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?
- Oral cannabis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2014
- 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
- Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
Show all 11Show fewer
- 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.).
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.
Show all 10Show fewer
- 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 orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of oral cannabis dose effects 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 we evaluated the detection of cannabinoids in oral fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg, 25mg, or 50mg THC). The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of oral cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.
- Conditions
- Cannabis
- Being tested
- Oral 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.
Oral cannabisDrug
| Study group | Role | What they receive |
|---|---|---|
| 10mg acute oral cannabis | Experimental | 10mg acute oral cannabis Receives: Drug: Oral cannabis |
| 25mg acute oral cannabis | Experimental | 25mg acute oral cannabis Receives: Drug: Oral cannabis |
| 50mg acute oral cannabis | Experimental | 50mg acute oral cannabis Receives: Drug: Oral cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood THC
Measured: baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
Urine THC-COOH
Measured: Baseline and 1, 2, 3, 4, 4-6 hours, 6-8 hours, 8-10 hours, 10-12 hours and then every 4 hours up until the 130 hour post exposure time point
Oral Fluid THC
Measured: baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
Subjective rating of "Drug Effect"
Visual analog scale ratings of subjective intoxication
Measured: baseline, immediately after exposure and 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 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 posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), RTI International
- Responsible party
- Principal investigator, Ryan Vandrey, Johns Hopkins University
- Investigators
- Ryan Vandrey, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165176
- Sponsor's protocol ID
- IRB00035394
- Status last verified
- Sep 2018
- First submitted
- 12 Jun 2014
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis
- ClinicalTrials.gov ID
- NCT02165176
- Acronym / sponsor ID
- IRB00035394
- Conditions
- Cannabis
- Keywords
- cannabis, toxicology, intoxication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA), RTI International
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Jun 2014 (estimated)
- 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 orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of oral cannabis dose effects 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 we evaluated the detection of cannabinoids in oral fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg, 25mg, or 50mg THC). The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of oral cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10mg acute oral cannabis | Experimental | Drug: Oral cannabis10mg acute oral cannabis |
| 25mg acute oral cannabis | Experimental | Drug: Oral cannabis25mg acute oral cannabis |
| 50mg acute oral cannabis | Experimental | Drug: Oral cannabis50mg acute oral cannabis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 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 |
|---|---|---|
| Oral cannabis | Drug | 10mg acute oral cannabis, 25mg acute oral cannabis, 50mg acute oral cannabis |
Primary outcome
Blood THC
Time frame: baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
Urine THC-COOH
Time frame: Baseline and 1, 2, 3, 4, 4-6 hours, 6-8 hours, 8-10 hours, 10-12 hours and then every 4 hours up until the 130 hour post exposure time point
Oral Fluid THC
Time frame: baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
Subjective rating of "Drug Effect"
Time frame: baseline, immediately after exposure and 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post exposure
Visual analog scale ratings of subjective intoxication
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 17 Sep 2018.
Related trials for Cannabis
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
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
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 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 11 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 17 Sep 2018. 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?
Blood THC (time frame: baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure). The study lists 4 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 17 Sep 2018.