Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

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.

Conditions

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

Interventions

DEVICE

Pax Loose Leaf Vaporizer

In all arms, participants will be using the PAX Loose Leave Vaporizer.

OTHER

Placebo Marijuana

Participants will vape placebo marijuana from the PAX device

DRUG

Nicotine

Participants will vape Regular and Very Low Nicotine content cigarettes from the PAX device

DRUG

Cannabis

Participants will vape marijuana in varying doses from the PAX device

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Food and Drug Administration (FDA)

  collaborator FED

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Gideon St Helen · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2028-02-01

Completion

2028-02-01

FDA Drug

Yes

Countries

• United States

Study Locations