Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
University of California, San Francisco
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.
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 el…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 u…
Interventions
- DrugCannabis
Participants will vape marijuana in varying doses from the PAX device
- DrugNicotine
Participants will vape Regular and Very Low Nicotine content cigarettes from the PAX device
- DevicePax Loose Leaf Vaporizer
In all arms, participants will be using the PAX Loose Leave Vaporizer.
- OtherPlacebo Marijuana
Participants will vape placebo marijuana from the PAX device
Location
- Zuckerberg San Francisco General HospitalSan Francisco, California