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Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration (CANNIC)

Primary Purpose

THC, Cannabis, Cannabis Use

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Nicotine
Pax Loose Leaf Vaporizer
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for THC focused on measuring THC, Cannabis, Marijuana, Nicotine, Vape

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Heart rate < 105 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 ≤ 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: Heart disease Seizures Cancer Thyroid disease (okay if controlled with medication) Diabetes Hepatitis B or C or Liver disease Glaucoma Kidney disease or urinary retention An ulcer in the past year Active use of an inhaler for asthma or COPD 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 Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol/drug treatment program Positive toxicology test at the screening visit (THC & prescribed medications okay) Opioid replacement therapy (including methadone, buprenorphine, or other) Psychiatric conditions Current or past schizophrenia, and/or current or past bipolar disorder Major depression, current or within the past year Major personality disorder Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI [study physician] and considered for inclusion History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's [study physician's] approval Current regular use of any psychiatric medications with the exception of SSRIs and SNRIs 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 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 Any stimulant medications (ex. Adderall) generally given for ADHD treatment Other/Misc. Chronic Health Problems Oral thrush Fainting Other "life threatening illnesses" as per study physician's discretion Pregnancy Pregnancy (self-reported and urine pregnancy test) Breastfeeding (determined by self-report) 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

Sites / Locations

  • Zuckerberg San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo marijuana and regular cigarette

Placebo marijuana and Very Low Nicotine Content cigarette

Medium marijuana and regular cigarette

Medium marijuana and Very Low Nicotine Content cigarette

High marijuana and regular cigarette

High marijuana and Very Low Nicotine Content cigarette

High marijuana only

Regular cigarette only

Arm Description

Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and regular cigarette (25.94 mg/g nicotine content)

Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)

Participants will vape a 50/50 mixture of medium marijuana (<5% THC) and regular cigarette (25.94 mg/g nicotine content)

Participants will vape a 50/50 mixture of medium marijuana (<5% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)

Participants will vape a 50/50 mixture of high marijuana (>10% THC) and regular cigarette (25.94 mg/g nicotine content)

Participants will vape a 50/50 mixture of high marijuana (>10% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)

Participants will vape high marijuana (>10% THC)

Participants will vape a regular cigarette (25.94 mg/g nicotine content)

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 11, 2023
Last Updated
August 11, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Food and Drug Administration (FDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05999383
Brief Title
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
Acronym
CANNIC
Official Title
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2028 (Anticipated)
Study Completion Date
October 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), Food and Drug Administration (FDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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 CTSI Clinical Research Services-supported research ward at Zuckerberg San Francisco General.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
THC, Cannabis, Cannabis Use, Cannabis Smoking, Tobacco Use, Vaping
Keywords
THC, Cannabis, Marijuana, Nicotine, Vape

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo marijuana and regular cigarette
Arm Type
Experimental
Arm Description
Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and regular cigarette (25.94 mg/g nicotine content)
Arm Title
Placebo marijuana and Very Low Nicotine Content cigarette
Arm Type
Experimental
Arm Description
Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)
Arm Title
Medium marijuana and regular cigarette
Arm Type
Experimental
Arm Description
Participants will vape a 50/50 mixture of medium marijuana (<5% THC) and regular cigarette (25.94 mg/g nicotine content)
Arm Title
Medium marijuana and Very Low Nicotine Content cigarette
Arm Type
Experimental
Arm Description
Participants will vape a 50/50 mixture of medium marijuana (<5% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)
Arm Title
High marijuana and regular cigarette
Arm Type
Experimental
Arm Description
Participants will vape a 50/50 mixture of high marijuana (>10% THC) and regular cigarette (25.94 mg/g nicotine content)
Arm Title
High marijuana and Very Low Nicotine Content cigarette
Arm Type
Experimental
Arm Description
Participants will vape a 50/50 mixture of high marijuana (>10% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)
Arm Title
High marijuana only
Arm Type
Experimental
Arm Description
Participants will vape high marijuana (>10% THC)
Arm Title
Regular cigarette only
Arm Type
Experimental
Arm Description
Participants will vape a regular cigarette (25.94 mg/g nicotine content)
Intervention Type
Drug
Intervention Name(s)
Cannabis
Intervention Description
Participants will vape marijuana in varying doses from the PAX device
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
Participants will vape regular and Very Low Nicotine content cigarettes from the PAX device
Intervention Type
Device
Intervention Name(s)
Pax Loose Leaf Vaporizer
Intervention Description
In all arms, participants will be using the PAX Loose Leave Vaporizer.
Primary Outcome Measure Information:
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Baseline and Day 1
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Day 1 and Day 2
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Day 2 and Day 3
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Day 3 and Day 4
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Day 4 and Day 5
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Day 5 and Day 6
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Day 6 and Day 7
Title
Change in peak plasma concentration of THC
Description
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.
Time Frame
Day 7 and Day 8
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Baseline and Day 1
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Day 1 and Day 2
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Day 2 and Day 3
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Day 3 and Day 4
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Day 4 and Day 5
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Day 5 and Day 6
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Day 6 and Day 7
Title
Change in Peak plasma concentration of nicotine
Description
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.
Time Frame
Day 7 and Day 8
Secondary Outcome Measure Information:
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Baseline and Day 1
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Day 1 and Day 2
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Day 2 and Day 3
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Day 3 and Day 4
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Day 4 and Day 5
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Day 5 and Day 6
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Day 6 and Day 7
Title
Cardiovascular effects among dosages using heart rate as a measure
Description
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.
Time Frame
Day 7 and Day 8
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Baseline and Day 1
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Day 1 and Day 2
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Day 2 and Day 3
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Day 3 and Day 4
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Day 4 and Day 5
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Day 5 and Day 6
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Day 6 and Day 7
Title
Area under the plasma concentration versus time curve (AUC)
Description
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.
Time Frame
Day 7 and Day 8
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Baseline and Day 1
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Day 1 and Day 2
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Day 2 and Day 3
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Day 3 and Day 4
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Day 4 and Day 5
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Day 5 and Day 6
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Day 6 and Day 7
Title
Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)
Description
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.
Time Frame
Day 7 and Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Heart rate < 105 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 ≤ 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: Heart disease Seizures Cancer Thyroid disease (okay if controlled with medication) Diabetes Hepatitis B or C or Liver disease Glaucoma Kidney disease or urinary retention An ulcer in the past year Active use of an inhaler for asthma or COPD 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 Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol/drug treatment program Positive toxicology test at the screening visit (THC & prescribed medications okay) Opioid replacement therapy (including methadone, buprenorphine, or other) Psychiatric conditions Current or past schizophrenia, and/or current or past bipolar disorder Major depression, current or within the past year Major personality disorder Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI [study physician] and considered for inclusion History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's [study physician's] approval Current regular use of any psychiatric medications with the exception of SSRIs and SNRIs 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 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 Any stimulant medications (ex. Adderall) generally given for ADHD treatment Other/Misc. Chronic Health Problems Oral thrush Fainting Other "life threatening illnesses" as per study physician's discretion Pregnancy Pregnancy (self-reported and urine pregnancy test) Breastfeeding (determined by self-report) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armando Barraza
Phone
6282064226
Email
armando.barraza@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gideon St Helen
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

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