Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05999383
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cannabis
  • Cannabis Smoking
  • Cannabis Use
  • THC
  • Tobacco Use
  • Vaping

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Cannabis — DRUG
    Participants will vape marijuana in varying doses from the PAX device
  • Nicotine — DRUG
    Participants will vape Regular and Very Low Nicotine content cigarettes from the PAX device
  • Pax Loose Leaf Vaporizer — DEVICE
    In all arms, participants will be using the PAX Loose Leave Vaporizer.
  • Placebo Marijuana — OTHER
    Participants will vape placebo marijuana from the PAX device

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jan 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Placebo marijuana and regular cigarette
    Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and regular cigarette (25.94 mg/g nicotine content)
  • Experimental: Placebo marijuana and Very Low Nicotine Content cigarette
    Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)
  • Experimental: Medium marijuana and regular cigarette
    Participants will vape a 50/50 mixture of medium marijuana (\<5% THC) and regular cigarette (25.94 mg/g nicotine content)
  • Experimental: Medium marijuana and Very Low Nicotine Content cigarette
    Participants will vape a 50/50 mixture of medium marijuana (\<5% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)
  • Experimental: High marijuana and regular cigarette
    Participants will vape a 50/50 mixture of high marijuana (\>10% THC) and regular cigarette (25.94 mg/g nicotine content)
  • Experimental: High marijuana and Very Low Nicotine Content cigarette
    Participants will vape a 50/50 mixture of high marijuana (\>10% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)
  • Experimental: High marijuana only
    Participants will vape high marijuana (\>10% THC)
  • Experimental: Regular cigarette only
    Participants will vape a regular cigarette (25.94 mg/g nicotine content)

Primary Outcome Measure

Change in peak plasma concentration of THC [ Time Frame: From Baseline to Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110
Lisa Lawrence
[email protected]
Gideon St. Helen, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Zuckerberg San Francisco General Hospital· San Francisco, CA

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