Actively Recruiting

Phase 2
Age: 21Years - 65Years
All Genders
Healthy Volunteers
NCT05999383

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

Led by University of California, San Francisco · Updated on 2026-01-07

48

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

Who Can Participate

Age: 21Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Heart rate less than 105 beats per minute
  • Systolic blood pressure between 90 and 160
  • Diastolic blood pressure between 50 and 100
  • Body Mass Index (BMI) of 38.0 or less
  • Current regular cannabis user who smokes or vapes at least three days per week for the past 3 months or more
  • Positive urine test for THC and self-report of cannabis use
  • Current daily user of inhaled tobacco or nicotine products for the past 3 months or more
  • Saliva cotinine level of 30 ng/mL or higher
Not Eligible

You will not qualify if you...

  • Unstable medical conditions including heart disease, seizures, cancer, uncontrolled thyroid disease, diabetes, hepatitis B or C, liver disease, glaucoma, kidney disease, urinary retention, recent ulcer, or active use of inhalers for asthma/COPD
  • Uncontrolled hypertension not under treatment
  • Alcohol or illicit drug dependence within the past 12 months (except recent completion of treatment)
  • Positive toxicology test at screening (except THC and prescribed medications)
  • Use of opioid replacement therapy
  • Current or past schizophrenia or bipolar disorder
  • Major depression currently or within the past year
  • Major personality disorder
  • Use of psychiatric medications except certain antidepressants if stable
  • Immunodeficiency disorders or chronic diseases affecting immunity
  • Traumatic brain injury
  • Recent or worsening cough, fever, or abdominal symptoms within two weeks
  • Use of medications that induce nicotine metabolism or concurrent nicotine medications
  • Use of stimulant medications like Adderall
  • Chronic health problems such as oral thrush or fainting
  • Pregnancy or breastfeeding
  • Participation in another clinical trial
  • Inability to communicate in English
  • History of marijuana-induced psychosis or paranoia
  • High severity of cannabis dependence (SDS score 7 or higher)
  • Planning to quit smoking or vaping tobacco or cannabis within 60 days
  • Uncomfortable with blood draws
  • Unable to abstain from tobacco and cannabis use for 13 hours before visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zuckerberg San Francisco General Hospital

San Francisco, California, United States, 94110

Actively Recruiting

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Research Team

A

Armando Barraza

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

8

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