Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: THC, Cannabis, Cannabis Use, Cannabis Smoking, Tobacco Use, Vaping

In brief

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 facts

Study ID

NCT05999383

Run by

University of California, San Francisco

People needed

48

Starts

2025-07-01

Expected to finish

2028-02-01

Last updated by the study team

2026-01-07

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 use
• Current user of inhaled forms of tobacco/nicotine (cigarette, cigars, e-cigarettes) who use the product daily for the past 3 months or more
• Saliva cotinine ≥ 30 ng/mL

You may not qualify if…

• Unstable medical conditions:
• Heart disease
• Seizures
• Cancer
• Thyroid disease (okay if controlled with medication)
• Diabetes
• Hepatitis B or C or Liver disease
• Glaucoma
• Kidney disease or urinary retention
• An ulcer in the past year
• Active use of an inhaler for asthma or Chronic Obstructive Pulmonary Disease (COPD)
• Hypertension if uncontrolled (meaning participant has a diagnosis, but they are not taking medication/under treatment (e.g., diet or exercise plan)
• Drug/Alcohol Dependence
• Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol/drug treatment program
• Positive toxicology test at the screening visit (THC \& prescribed medications okay)
• Opioid replacement therapy (including methadone, buprenorphine, or other)
• Psychiatric conditions
• Current or past schizophrenia, and/or current or past bipolar disorder
• Major depression, current or within the past year
• Major personality disorder
• Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI [study physician] and considered for inclusion
• History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's [study physician's] approval
• Current regular use of any psychiatric medications with the exception of Selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate
• Congenital or acquired immunodeficiency disorders (i.e. HIV, congenital immune deficiency syndrome, chronic diseases)
• Other disorders (i.e. ICU, malnutrition, immunosuppressive therapy)

Where it is running

• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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