Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Heart rate < 105 beats per minute (BPM)*
Systolic Blood Pressure < 160 and > 90*
Diastolic Blood Pressure < 100 and > 50*
Body Mass Index (BMI) ≤ 38.0 (at investigator's discretion for higher BMI if no other concurrent health issues)
Disqualifiers
Heart disease
Seizures
Cancer
Thyroid disease (okay if controlled with medication)
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabis
DrugParticipants will vape marijuana in varying doses from the PAX device
Nicotine
DrugParticipants will vape Regular and Very Low Nicotine content cigarettes from the PAX device
Pax Loose Leaf Vaporizer
DeviceIn all arms, participants will be using the PAX Loose Leave Vaporizer.
Placebo Marijuana
Other interventionParticipants will vape placebo marijuana from the PAX device
Treatment groups
48 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Placebo marijuana and regular cigaretteExperimental treatment 3 interventions
Group B: Placebo marijuana and Very Low Nicotine Content cigaretteExperimental treatment 3 interventions
Group C: Medium marijuana and regular cigaretteExperimental treatment 3 interventions
Group D: Medium marijuana and Very Low Nicotine Content cigaretteExperimental treatment 3 interventions
Group E: High marijuana and regular cigaretteExperimental treatment 3 interventions
Group F: High marijuana and Very Low Nicotine Content cigaretteExperimental treatment 3 interventions
Group G: High marijuana onlyExperimental treatment 2 interventions
Group H: Regular cigarette onlyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
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.
Time frame
From Baseline to Day 12
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.
Time frame
From Day 1 to Day 23
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.
Time frame
From Day 2 to Day 34
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.
Time frame
From Day 3 to Day 4Secondary outcomes
1
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.
Time frame
From Baseline to Day 12
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.
Time frame
From Day 1 to Day 23
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.
Time frame
From Day 2 to Day 34
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.
Time frame
From Day 3 to Day 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
National Institutes of Health (NIH)
Collaborator
Food and Drug Administration (FDA)
Collaborator
Source ClinicalTrials.gov