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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA056451-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institutes of Health (NIH) | NIH |
| Food and Drug Administration (FDA) | FED |
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This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. The project aims to describe the pharmacokinetics and pharmacodynamics of marijuana-tobacco co-administration by delivering THC and nicotine in various combinations. This foundational study will establish a research program focused on elucidating the public health consequences of marijuana-tobacco co-use.
This is a single-center, within-subject (crossover), randomized, double-blinded clinical pharmacology study of over 8 study visits (days). Participants will be non-treatment-seeking, healthy frequent users of both marijuana and tobacco/nicotine, age 21 to 65 years (21 years because of California tobacco control law). Participants will be marijuana users of any race who smoke or vape marijuana or THC extracts at least three days a week for the past 3 months or more. The study investigators will use positive urine toxicology THC results and self-report of marijuana smoking/vaping to determine eligibility. Participants must also be current users of inhaled forms of tobacco/nicotine (cigarettes, cigars, e-cigarettes) who use the product daily over the past 3 months.
Each study day will consist of a standardized session of 5 puffs of one of 8 study conditions using a PAX-3 vaporizer (PAX Labs, Inc.). Blood will be sampled multiple times for plasma THC, nicotine, and catecholamines, questionnaires administered for sensory and subjective effects, and heart rate, skin blood flow, and skin temperature will be measured. After 6 hours of abstinence, participants will have 60 minutes of ad libitum access to the assigned study condition, during which heart rate and blood pressure will be continuously monitored, blood sampled before and after for THC, nicotine, and platelet aggregation measured, and questionnaires administered.
Studies will be conducted at the Clinical & Translational Science Institute (CTSI) Clinical Research Services-supported research ward at Zuckerberg San Francisco General.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo marijuana and regular cigarette | Experimental | Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and regular cigarette (25.94 mg/g nicotine content) |
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| Placebo marijuana and Very Low Nicotine Content cigarette | Experimental | Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content) |
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| Medium marijuana and regular cigarette | Experimental | Participants will vape a 50/50 mixture of medium marijuana (<5% THC) and regular cigarette (25.94 mg/g nicotine content) |
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| Medium marijuana and Very Low Nicotine Content cigarette | Experimental | Participants will vape a 50/50 mixture of medium marijuana (<5% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content) |
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| High marijuana and regular cigarette |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | Participants will vape marijuana in varying doses from the PAX device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. | From Baseline to Day 1 |
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. | From Day 1 to Day 2 |
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. | From Day 2 to Day 3 |
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. | From Day 3 to Day 4 |
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. | From Day 4 to Day 5 |
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular effects among dosages using heart rate as a measure | The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. | From Baseline to Day 1 |
| Cardiovascular effects among dosages using heart rate as a measure |
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Inclusion Criteria:
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.
Body Mass Index (BMI) ≤ 38.0 (at investigator's discretion for higher BMI if no other concurrent health issues)
Current regular user of cannabis who smokes or vapes cannabis or THC extracts at least three days a week for the past 3 months or more
Test positive for D-9-tetrahydrocannabinol (THC) at screening and self-report of cannabis use
Current user of inhaled forms of tobacco/nicotine (cigarette, cigars, e-cigarettes) who use the product daily for the past 3 months or more
Saliva cotinine ≥ 30 ng/mL
Exclusion Criteria:
Unstable medical conditions:
Hypertension if uncontrolled (meaning participant has a diagnosis, but they are not taking medication/under treatment (e.g., diet or exercise plan)
Drug/Alcohol Dependence
Psychiatric conditions
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 PI that the participant is otherwise healthy, stable, and able to participate
Congenital or acquired immunodeficiency disorders (i.e. HIV, congenital immune deficiency syndrome, chronic diseases)
Other disorders (i.e. ICU, malnutrition, immunosuppressive therapy)
Traumatic brain injury
Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
Medications
Other/Misc. Chronic Health Problems
Pregnancy
Concurrent participation in another clinical trial
Inability to communicate in English
History of marijuana-induced psychosis or paranoia after smoking marijuana
Scoring a 7 or higher on the Severity of Dependence Scale (SDS) for cannabis use
Planning to quit smoking or vaping within the next 60 days
Planning to quit cannabis use within the next 60 days
Uncomfortable with getting blood drawn
Willingness to abstain from tobacco smoking and all combustible products for 13 hours before admission
Willingness to abstain from smoking/ingestion of cannabis 13 hours before
Willingness to abstain from nicotine products 13 hours before each admission
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Armando Barraza | Contact | 628-206-4226 | armando.barraza@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gideon St Helen | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D008385 | Marijuana Smoking |
| D064424 | Tobacco Use |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000074609 | Marijuana Use |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Participants will vape a 50/50 mixture of high marijuana (>10% THC) and regular cigarette (25.94 mg/g nicotine content) |
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| High marijuana and Very Low Nicotine Content cigarette | Experimental | Participants will vape a 50/50 mixture of high marijuana (>10% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content) |
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| High marijuana only | Experimental | Participants will vape high marijuana (>10% THC) |
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| Regular cigarette only | Experimental | Participants will vape a regular cigarette (25.94 mg/g nicotine content) |
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| Nicotine | Drug | Participants will vape Regular and Very Low Nicotine content cigarettes from the PAX device |
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| Pax Loose Leaf Vaporizer | Device | In all arms, participants will be using the PAX Loose Leave Vaporizer. |
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| Placebo Marijuana | Other | Participants will vape placebo marijuana from the PAX device |
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| From Day 5 to Day 6 |
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. | From Day 6 to Day 7 |
| Change in peak plasma concentration of THC | To assess the differences between THC dosages, the study investigators will determine maximum plasma THC concentration (Cmax) using plasma THC concentrations from the standardized sessions. | From Day 7 to Day 8 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Baseline to Day 1 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Day 1 to Day 2 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Day 2 to Day 3 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Day 3 to Day 4 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Day 4 to Day 5 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Day 5 to Day 6 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Day 6 to Day 7 |
| Change in Peak plasma concentration of nicotine | To assess the differences between nicotine dosages, the study investigators will determine maximum plasma nicotine concentration (Cmax) using plasma nicotine concentrations from the standardized sessions. | From Day 7 to Day 8 |
The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. |
| From Day 1 to Day 2 |
| Cardiovascular effects among dosages using heart rate as a measure | The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. | From Day 2 to Day 3 |
| Cardiovascular effects among dosages using heart rate as a measure | The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. | From Day 3 to Day 4 |
| Cardiovascular effects among dosages using heart rate as a measure | The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. | From Day 4 to Day 5 |
| Cardiovascular effects among dosages using heart rate as a measure | The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. | From Day 5 to Day 6 |
| Cardiovascular effects among dosages using heart rate as a measure | The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. | From Day 6 to Day 7 |
| Cardiovascular effects among dosages using heart rate as a measure | The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate over the first 180 minutes after the standardized session among dosages. | From Day 7 to Day 8 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Baseline to Day 1 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Day 1 to Day 2 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Day 2 to Day 3 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Day 3 to Day 4 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Day 4 to Day 5 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Day 5 to Day 6 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Day 6 to Day 7 |
| Area under the plasma concentration versus time curve (AUC) | To assess the differences of absorption among dosages, the study investigators will determine the AUC using plasma nicotine and THC concentrations from the standardized sessions. | From Day 7 to Day 8 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased cravings. | From Baseline to Day 1 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased craving of marijuana. | From Day 1 to Day 2 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased cravings. | From Day 2 to Day 3 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased cravings. | From Day 3 to Day 4 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased cravings. | From Day 4 to Day 5 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased cravings. | From Day 5 to Day 6 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased cravings. | From Day 6 to Day 7 |
| Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ) | Self-assessed cravings will be measured using the MCQ. Questions on the MCQ are scored on a 7 point scale of 1 = Strongly Disagree and 7 = Strongly Disagree, with higher scores indicating increased cravings. | From Day 7 to Day 8 |
| D001519 | Behavior |
| D000073847 | Smoking, Non-Tobacco Products |
| D012907 | Smoking |
| D006573 |
| Heterocyclic Compounds, 1-Ring |