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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration (NCT05999383) is a Phase 2 interventional studying THC and Cannabis, sponsored by University of California, San Francisco. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against THC and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 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 Exclusion Criteria: * 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) * Traumatic brain injury * Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks * Medications * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs) * Concurrent use of nicotine-containing medications * Any stimulant medications (ex. Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment * Other/Misc. Chronic Health Problems * Oral thrush * Fainting * Other "life threatening illnesses" as per study physician's discretion * Pregnancy * Pregnancy (self-reported and urine pregnancy test) * Breastfeeding (determined by self-report) * Concurrent participation in another clinical trial * Inability to communicate in English * History of marijuana-induced psychosis or paranoia after smoking marijuana * Scoring a 7 or higher on the Severity of Dependence Scale (SDS) for cannabis use * Planning to quit smoking or vaping within the next 60 days * Planning to quit cannabis use within the next 60 days * Uncomfortable with getting blood drawn * Willingness to abstain from tobacco smoking and all combustible products for 13 hours before admission * Willingness to abstain from smoking/ingestion of cannabis 13 hours before * Willingness to abstain from nicotine products 13 hours before each admission

Treatments Being Tested

DRUG

Cannabis

Participants will vape marijuana in varying doses from the PAX device

DRUG

Nicotine

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

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Zuckerberg San Francisco General Hospital
San Francisco, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05999383), the sponsor (University of California, San Francisco), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05999383 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05999383?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05999383?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05999383. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05999383. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.