THCTRDRPNCT04429568
THC Crossover Study
A study testing Smoked Cannabis, Vaped Cannabis and Tobacco Cigarette in people with THC and Cannabis, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- THC, Cannabis, Cannabis Smoking
- What is being tested?
- Smoked Cannabis, Vaped Cannabis and Tobacco Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2020to 25 Jun 2024
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy on the basis of medical history and limited physical examination, as described below:
- Heart rate < 105 beats per minute (BPM); Systolic Blood Pressure < 160 and > 90; Diastolic Blood Pressure < 100 and > 50
- Considered out of range if both machine and manual readings are above/below these thresholds.
- Current regular user of cannabis who smokes cannabis as joint or blunt at least 3 times a week for past 3 months
- History of cannabis vaporizer use or willingness to use the vaporizer in the study
- Current tobacco cigarette use who smokes ≥ 5 cigarettes per day
- Saliva cotinine ≥ 50 ng/ml
- Test positive for D-9-tetrahydrocannabinol (THC) at screening and self-report of cannabis use
Who cannot join
- Unstable medical conditions:
- Heart disease; Uncontrolled hypertension; Thyroid disease (okay if controlled with medication); Diabetes; Hepatitis B or C or Liver disease; Glaucoma; Prostatic hypertrophy
- Psychiatric conditions:
- Current or past schizophrenia, and/or current or past bipolar disorder; Adult onset attention deficit hyperactivity disorder (ADHD); Participants with current or past depression and/or anxiety disorders will be reviewed by the study physician and considered for inclusion; History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per study physician's approval
- Concurrent regular use of smokeless tobacco or pipes [occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study]
- Medications:
Show all 18Show fewer
- Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs).; Concurrent use of nicotine-containing medications; Psychiatric medications: current regular use of any psychiatric medications with the exception of Selective Serotonin Reuptake Inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) and current evaluation by the study physician that the participant is otherwise healthy, stable, and able to participate.
- Other/Misc. Chronic Health Conditions:
- Oral thrush; Fainting; Untreated thyroid disease; Other "life threatening illnesses" as per study physician's discretion
- Pregnancy:
- Pregnancy (self-reported and urine pregnancy test); Breastfeeding (determined by self-report)
- Drug/Alcohol Dependence:
- Alcohol or illicit drug dependence within the past 12 months with the exception of those who have recently completed an alcohol/drug treatment program; Positive toxicology test at the screening visit (THC \& prescribed medications okay); Methadone replacement therapy
- Concurrent participation in another clinical trial
- Inability to communicate in English
- History of marijuana-induced psychosis or paranoia after smoking marijuana
- Scoring a 2 or higher on the Severity of Dependence Scale for cannabis use
- Planning to quit smoking or vaping within the next 60 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Cardiovascular Effects of Cannabis Compared to Tobacco Use
This is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.
Read the detailed description
Experienced dual cannabis-tobacco smokers will participate in a within-subject crossover study with three blocks: smoked cannabis (purchased by participants from a local dispensary), dry herb cannabis vaporizer, and usual brand tobacco cigarette. Each block will consist of 2 consecutive days on an inpatient research ward. The first inpatient day of each block will comprise of two sessions: (1) The first session will be a standardized bout to compare pharmacokinetic, physiologic, and subjective effects of cannabis and tobacco use; (2) after 6 hours of abstinence, the second session will be ad libitum access to the assigned product for 2 hours to compare subjective effects (reward, satisfaction, craving reduction) and use patterns. The second inpatient day will consist of ad libitum use of the assigned product from 8:00 in the morning to midnight. An abstinence day will be added after the second day of the last block to assess exposure and effects biomarkers during a period of abstinence from cannabis (smoked/vaped) or tobacco.
- Conditions
- THC, Cannabis, Cannabis Smoking, Cannabis Use, Unspecified, Cigarette Smoking, Tobacco Use
- Being tested
- Smoked Cannabis, Vaped Cannabis, Tobacco Cigarette
- Keywords
- vape, cannabis, tobacco cigarette, thc, marijuana, smoking
- Medical subject headings
- Marijuana Abuse, Marijuana Smoking, Cigarette Smoking, Tobacco Use, Tobacco Use Disorder, Vaping, Wiskott-Aldrich Syndrome, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked CannabisOther
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff.
Vaped CannabisOther
Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers.
Tobacco CigaretteOther
Tobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study.
| Study group | Role | What they receive |
|---|---|---|
| Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette | Other | * Abstinence from any product night before hospital admission
* Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette
* 6-hr abstinence and blood draws (PK)
* 2 hr Free use session w/ video monitoring
* Free use of assigned product
* 12-hr cardiovascular (CV) monitoring
* Circadian blood draws
* 12-hr urine collection Receives: Other: Smoked Cannabis; Other: Vaped Cannabis; Other: Tobacco Cigarette |
| Either of the 2 remaining products | Other | * Abstinence from any product night before hospital admission
* Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette
* 6-hr abstinence and blood draws (PK)
* 2 hr Free use session w/ video monitoring
* Free use of assigned product
* 12-hr CV monitoring
* Circadian blood draws
* 12-hr urine collection Receives: Other: Smoked Cannabis; Other: Vaped Cannabis; Other: Tobacco Cigarette |
| Remaining product | Other | * Abstinence from any product night before hospital admission
* Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette
* 6-hr abstinence and blood draws (PK)
* 2 hr Free use session w/ video monitoring
* Free use of assigned product
* 12-hr CV monitoring
* Circadian blood draws
* 12-hr urine collection Receives: Other: Smoked Cannabis; Other: Vaped Cannabis; Other: Tobacco Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration
To assess the differences between smoked and vaped cannabis, we will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions.
Measured: Day 1 of each arm
Time to peak plasma concentration
To assess the differences of these variables between smoked and vaped cannabis, we will determine the time to max concentration (Tmax) using plasma THC concentrations from the standardized sessions.
Measured: Day 1 of each arm
Area under the plasma concentration versus time curve (AUC)
To assess the differences of these variables between smoked and vaped cannabis, we will determine the AUC using plasma THC concentrations from the standardized sessions.
Measured: Day 1 of each arm
Subjective effects between cannabis products using the Marijuana Cravings Questionnaire
We will assess measures from the Marijuana Cravings Questionnaire (MCQ) and compare them between smoked and vaped cannabis.
Measured: Days 1-2 of each arm
Subjective effects between cannabis products using the Visual Analog Scale
We will assess measures from the Visual Analog Scale (VAS) and compare them between smoked and vaped cannabis.
Measured: Days 1-2 of each arm
Subjective effects between cannabis products using the Drug Effects Questionnaire
We will assess measures from the Drug Effects Questionnaire (DEQ) and compare them between smoked and vaped cannabis.
Measured: Days 1-2 of each arm
Max change of expired carbon monoxide
We will examine differences in max change of expired carbon monoxide (CO) from day 1 between smoked and vaped cannabis.
Measured: Days 1-2 of the cannabis arms
Area under the expired carbon monoxide (CO) curve (AUC)
We will examine differences in integrated AUC of expired carbon monoxide from day 1 between smoked and vaped cannabis.
Measured: Days 1-2 of the cannabis arms
Differences in metabolites of volatile organic compounds (VOCs)
We will examine differences in 12-hour urine mercapturic acid metabolites of volatile organic compounds (from day 2) between smoked and vaped cannabis.
Measured: Days 1-2 of the cannabis arms
Exposure to toxicants between cannabis products
We will also examine how measures of use (number of puss, amount use, number of use episodes) correlate with biomarker concentrations between smoked and vaped cannabis.
Measured: Days 1-2 of the cannabis arms
Cardiovascular effects between cannabis products using heart rate as a measure
We will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 30 minutes after the standardized session (day 1) between smoked and vaped cannabis.
Measured: Day 1 of each arm
Cardiovascular effects between cannabis products using epinephrine as a measure
Urine catecholamine excretion, particularly epinephrine, will be examined in 12-hour urines and compared between smoked and vaped cannabis.
Measured: Day 2 of each cannabis arm
Cardiovascular effects between cannabis products using platelet activation as a measure
We will examine differences in blood and urine biomarkers of platelet activation between smoked and vaped cannabis.
Measured: Day 2 of each cannabis arm
Cardiovascular effects between cannabis products using oxidant stress as a measure
We will examine differences in blood and urine biomarkers of oxidant stress between smoked and vaped cannabis.
Measured: Day 2 of each cannabis arm
Cardiovascular effects between cannabis products using endothelial dysfunction as a measure
We will examine differences in blood and urine biomarkers of endothelial dysfunction and inflammation between smoked and vaped cannabis.
Measured: Day 2 of each cannabis arm
Secondary outcomes (9)
Toxicant exposure between smoked tobacco and cannabis using expired carbon monoxide as the measure
We will examine differences in expired carbon monoxide (CO) from day 1 (both max change and integrated AUC of expired CO) between smoked tobacco and cannabis.
Measured: Day 1 of each arm
Toxicant exposure between smoked tobacco and cannabis using mercapturic acid as the measure
We will examine differences in 12-hour urine mercapturic acid metabolites of volatile organic compounds (VOCs) (from day 2) between smoked tobacco and cannabis.
Measured: Day 2 of each arm
Toxicant exposure between smoked tobacco and cannabis using use as a measure
We will also examine how measures of use (number of puffs, amount use, number of use episodes) correlate with biomarker concentrations between smoked tobacco and cannabis.
Measured: Days 1-2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using heart rate as a measure
We will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 30 minutes after the standardized session (day 1) between smoked tobacco and cannabis.
Measured: Day 1 of each arm
Cardiovascular effects between smoked tobacco and cannabis using epinephrine as a measure
Urine catecholamine excretion, particularly epinephrine, will be examined in 12-hour urines.
Measured: Day 2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using platelet activation as a measure
We will examine differences in blood and urine biomarkers of platelet activation between smoked tobacco and cannabis.
Measured: Day 2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using oxidant stress as a measure
We will examine differences in blood and urine biomarkers of oxidant stress between smoked tobacco and cannabis.
Measured: Day 2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using endothelial dysfunction as a measure
We will examine differences in blood and urine biomarkers of endothelial dysfunction and inflammation between smoked tobacco and cannabis.
Measured: Day 2 of each arm
Puffing behaviors across all products
We will examine how puffing behaviors are different between all products (smoked and vaped cannabis, as well as with smoked tobacco cigarettes) and how they correlate with toxicant biomarker concentrations. Vaping topography measures will be obtained from frame by frame analysis of high definition videos.
Measured: Days 1-2 of each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start30 Oct 2020
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THCStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Gideon St. Helen, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429568
- Sponsor's protocol ID
- 17-24117
- Acronym
- TRDRP
- Status last verified
- Jun 2024
- First submitted
- 20 Aug 2019
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Cannabis Compared to Tobacco Use
- ClinicalTrials.gov ID
- NCT04429568
- Acronym / sponsor ID
- TRDRP / 17-24117
- Conditions
- THC, Cannabis, Cannabis Smoking, Cannabis Use, Unspecified, Cigarette Smoking, Tobacco Use
- Keywords
- vape, cannabis, tobacco cigarette, thc, marijuana, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 12 Jun 2020 (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 is a randomized, crossover study enrolling experienced dual cannabis-tobacco smokers (N=18) to describe the differences in THC and toxicant exposure, examining pharmacokinetic, subjective, and cardiovascular effects from smoking and vaping dry herb cannabis. This study will also examine the differences in toxicant exposure and cardiovascular disease risk between smoking cannabis and smoking tobacco cigarettes.
Detailed description
Experienced dual cannabis-tobacco smokers will participate in a within-subject crossover study with three blocks: smoked cannabis (purchased by participants from a local dispensary), dry herb cannabis vaporizer, and usual brand tobacco cigarette. Each block will consist of 2 consecutive days on an inpatient research ward. The first inpatient day of each block will comprise of two sessions: (1) The first session will be a standardized bout to compare pharmacokinetic, physiologic, and subjective effects of cannabis and tobacco use; (2) after 6 hours of abstinence, the second session will be ad libitum access to the assigned product for 2 hours to compare subjective effects (reward, satisfaction, craving reduction) and use patterns. The second inpatient day will consist of ad libitum use of the assigned product from 8:00 in the morning to midnight. An abstinence day will be added after the second day of the last block to assess exposure and effects biomarkers during a period of abstinence from cannabis (smoked/vaped) or tobacco.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette | Other | Other: Smoked Cannabis, Other: Vaped Cannabis, Other: Tobacco Cigarette* Abstinence from any product night before hospital admission * Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette * 6-hr abstinence and blood draws (PK) * 2 hr Free use session w/ video monitoring * Free use of assigned product * 12-hr cardiovascular (CV) monitoring * Circadian blood draws * 12-hr urine collection |
| Either of the 2 remaining products | Other | Other: Smoked Cannabis, Other: Vaped Cannabis, Other: Tobacco Cigarette* Abstinence from any product night before hospital admission * Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette * 6-hr abstinence and blood draws (PK) * 2 hr Free use session w/ video monitoring * Free use of assigned product * 12-hr CV monitoring * Circadian blood draws * 12-hr urine collection |
| Remaining product | Other | Other: Smoked Cannabis, Other: Vaped Cannabis, Other: Tobacco Cigarette* Abstinence from any product night before hospital admission * Standardized Session of assigned product: smoked cannabis, vaped cannabis, or tobacco cigarette * 6-hr abstinence and blood draws (PK) * 2 hr Free use session w/ video monitoring * Free use of assigned product * 12-hr CV monitoring * Circadian blood draws * 12-hr urine collection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy on the basis of medical history and limited physical examination, as described below:
- Heart rate < 105 beats per minute (BPM); Systolic Blood Pressure < 160 and > 90; Diastolic Blood Pressure < 100 and > 50
- Considered out of range if both machine and manual readings are above/below these thresholds.
- Current regular user of cannabis who smokes cannabis as joint or blunt at least 3 times a week for past 3 months
- History of cannabis vaporizer use or willingness to use the vaporizer in the study
Key exclusion criteria (18 listed)
- Unstable medical conditions:
- Heart disease; Uncontrolled hypertension; Thyroid disease (okay if controlled with medication); Diabetes; Hepatitis B or C or Liver disease; Glaucoma; Prostatic hypertrophy
- Psychiatric conditions:
- Current or past schizophrenia, and/or current or past bipolar disorder; Adult onset attention deficit hyperactivity disorder (ADHD); Participants with current or past depression and/or anxiety disorders will be reviewed by the study physician and considered for inclusion; History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per study physician's approval
- Concurrent regular use of smokeless tobacco or pipes [occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study]
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 |
|---|---|---|
| Smoked CannabisCannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. | Other | Either of the 2 remaining products, Remaining product, Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette |
| Vaped CannabisCannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers. | Other | Either of the 2 remaining products, Remaining product, Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette |
| Tobacco CigaretteTobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study. | Other | Either of the 2 remaining products, Remaining product, Smoked Cannabis, Vaped Cannabis, or Tobacco Cigarette |
Primary outcome
Peak plasma concentration
Time frame: Day 1 of each arm
To assess the differences between smoked and vaped cannabis, we will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions.
Time to peak plasma concentration
Time frame: Day 1 of each arm
To assess the differences of these variables between smoked and vaped cannabis, we will determine the time to max concentration (Tmax) using plasma THC concentrations from the standardized sessions.
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 of each arm
To assess the differences of these variables between smoked and vaped cannabis, we will determine the AUC using plasma THC concentrations from the standardized sessions.
Subjective effects between cannabis products using the Marijuana Cravings Questionnaire
Time frame: Days 1-2 of each arm
We will assess measures from the Marijuana Cravings Questionnaire (MCQ) and compare them between smoked and vaped cannabis.
Subjective effects between cannabis products using the Visual Analog Scale
Time frame: Days 1-2 of each arm
We will assess measures from the Visual Analog Scale (VAS) and compare them between smoked and vaped cannabis.
Subjective effects between cannabis products using the Drug Effects Questionnaire
Time frame: Days 1-2 of each arm
We will assess measures from the Drug Effects Questionnaire (DEQ) and compare them between smoked and vaped cannabis.
Max change of expired carbon monoxide
Time frame: Days 1-2 of the cannabis arms
We will examine differences in max change of expired carbon monoxide (CO) from day 1 between smoked and vaped cannabis.
Area under the expired carbon monoxide (CO) curve (AUC)
Time frame: Days 1-2 of the cannabis arms
We will examine differences in integrated AUC of expired carbon monoxide from day 1 between smoked and vaped cannabis.
Differences in metabolites of volatile organic compounds (VOCs)
Time frame: Days 1-2 of the cannabis arms
We will examine differences in 12-hour urine mercapturic acid metabolites of volatile organic compounds (from day 2) between smoked and vaped cannabis.
Exposure to toxicants between cannabis products
Time frame: Days 1-2 of the cannabis arms
We will also examine how measures of use (number of puss, amount use, number of use episodes) correlate with biomarker concentrations between smoked and vaped cannabis.
Cardiovascular effects between cannabis products using heart rate as a measure
Time frame: Day 1 of each arm
We will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 30 minutes after the standardized session (day 1) between smoked and vaped cannabis.
Cardiovascular effects between cannabis products using epinephrine as a measure
Time frame: Day 2 of each cannabis arm
Urine catecholamine excretion, particularly epinephrine, will be examined in 12-hour urines and compared between smoked and vaped cannabis.
Cardiovascular effects between cannabis products using platelet activation as a measure
Time frame: Day 2 of each cannabis arm
We will examine differences in blood and urine biomarkers of platelet activation between smoked and vaped cannabis.
Cardiovascular effects between cannabis products using oxidant stress as a measure
Time frame: Day 2 of each cannabis arm
We will examine differences in blood and urine biomarkers of oxidant stress between smoked and vaped cannabis.
Cardiovascular effects between cannabis products using endothelial dysfunction as a measure
Time frame: Day 2 of each cannabis arm
We will examine differences in blood and urine biomarkers of endothelial dysfunction and inflammation between smoked and vaped cannabis.
9 secondary outcomes
Toxicant exposure between smoked tobacco and cannabis using expired carbon monoxide as the measure
Time frame: Day 1 of each arm
Toxicant exposure between smoked tobacco and cannabis using mercapturic acid as the measure
Time frame: Day 2 of each arm
Toxicant exposure between smoked tobacco and cannabis using use as a measure
Time frame: Days 1-2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using heart rate as a measure
Time frame: Day 1 of each arm
Cardiovascular effects between smoked tobacco and cannabis using epinephrine as a measure
Time frame: Day 2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using platelet activation as a measure
Time frame: Day 2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using oxidant stress as a measure
Time frame: Day 2 of each arm
Cardiovascular effects between smoked tobacco and cannabis using endothelial dysfunction as a measure
Time frame: Day 2 of each arm
Puffing behaviors across all products
Time frame: Days 1-2 of each arm
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 1 Jul 2024.
- 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.
Gideon St. Helen, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoked Cannabis, Vaped Cannabis and Tobacco Cigarette in people with THC and Cannabis, run by University of California, San Francisco at 2 sites 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 18 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Peak plasma concentration (time frame: Day 1 of each arm). The study lists 15 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 1 Jul 2024.