Vaporized Cannabis + Nicotine for Cannabis and Tobacco Use

(CANNIC Trial)

Overseen By Armando Barraza

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Anticonvulsants, Stimulants, Nicotine medications

Disqualifiers: Heart disease, Cancer, Diabetes, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 8 days

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the effects of using cannabis and tobacco together. Researchers will examine how these substances interact in the body when inhaled in different combinations. Participants will vape various mixtures, such as high-THC marijuana with regular cigarettes or placebo marijuana with low-nicotine cigarettes. This trial suits regular cannabis and tobacco users who smoke or vape multiple times a week.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires you to stop using certain medications, like those that affect nicotine metabolism and stimulant medications for ADHD. You also need to avoid nicotine and cannabis products for 13 hours before each admission.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that vaping cannabis poses risks to lung health. Studies have found that it might cause more lung problems than smoking cigarettes or cannabis alone. Vaping also exposes users to harmful chemicals.

Using high THC marijuana in vaping can lead to increased breathing issues. Concerns also exist about potential heart-related effects from cannabis use.

For those using medium THC marijuana with nicotine, limited safety information is available. However, serious side effects, such as hallucinations or psychosis, may occur.

While vaping might produce fewer harmful emissions than smoking, it still carries risks. The study is in an early phase, and researchers are still reviewing safety data. Participants should consider these factors before deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the combined effects of cannabis and tobacco, which is an area not fully understood yet. Unlike traditional treatments for cannabis or tobacco dependency, which often involve behavioral therapy or medications like nicotine replacement therapy and varenicline, these experimental treatments focus on the unique interaction between THC and nicotine. This trial might reveal how different THC concentrations—ranging from high to placebo—interact with varying nicotine levels, potentially uncovering new strategies to address use and addiction. By experimenting with vaporized delivery, researchers aim to better understand how these substances co-administrate in real-world settings, offering insights that could lead to more effective interventions.

What evidence suggests that this trial's treatments could be effective for cannabis and tobacco use?

Research shows that people who use cannabis often smoke more cigarettes and struggle to quit smoking. Studies have found that using both cannabis and cigarettes can make quitting more difficult by increasing tobacco cravings. Additionally, heavy cannabis use can cause health problems, particularly for the heart. Some evidence suggests that people often perceive cannabis as safer than tobacco, influencing their usage patterns. This trial will explore various combinations of cannabis and nicotine, including high THC cannabis with regular cigarettes, to understand their effects on smoking behavior and health risks. Overall, using high THC cannabis with cigarettes may hinder smoking cessation and increase health risks. ^{6 7 8 9 10}

Who Is on the Research Team?

Gideon St. Helen, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for regular cannabis and tobacco users who smoke or vape at least three times a week for the past three months. Participants must have stable vital signs, a BMI ≤ 38 (exceptions possible), and test positive for THC. Exclusions include severe psychiatric conditions, certain chronic diseases, recent drug/alcohol dependence treatment, pregnancy, inability to communicate in English, plans to quit smoking/vaping soon, discomfort with blood draws.

Inclusion Criteria

Systolic Blood Pressure < 160 and > 90

Heart rate < 105 BPM

Diastolic Blood Pressure < 100 and > 50

Exclusion Criteria

I have chronic health issues like oral thrush or fainting, or other serious illnesses as determined by my doctor.

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

I do not have any uncontrolled health conditions like heart disease, seizures, or diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo 8 study visits with various combinations of marijuana and tobacco using a PAX-3 vaporizer, with multiple assessments including blood sampling and questionnaires.

8 days

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

Trial Overview The study investigates how using cannabis and tobacco together affects the body by testing different combinations of THC and nicotine delivery through vaporizers. It's a crossover study where participants will try each combination in random order under double-blind conditions—neither they nor the researchers know which combination is being used at any time.

How Is the Trial Designed?

Group I: Regular cigarette only Experimental Treatment 2 Interventions

Participants will vape a regular cigarette (25.94 mg/g nicotine content)

Group II: Placebo marijuana and regular cigarette Experimental Treatment 4 Interventions

Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and regular cigarette (25.94 mg/g nicotine content)

Group III: Placebo marijuana and Very Low Nicotine Content cigarette Experimental Treatment 4 Interventions

Participants will vape a 50/50 mixture of placebo marijuana (0% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)

Group IV: Medium marijuana and regular cigarette Experimental Treatment 3 Interventions

Participants will vape a 50/50 mixture of medium marijuana (\<5% THC) and regular cigarette (25.94 mg/g nicotine content)

Group V: Medium marijuana and Very Low Nicotine Content cigarette Experimental Treatment 3 Interventions

Participants will vape a 50/50 mixture of medium marijuana (\<5% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)

Group VI: High marijuana only Experimental Treatment 2 Interventions

Participants will vape high marijuana (\>10% THC)

Group VII: High marijuana and regular cigarette Experimental Treatment 3 Interventions

Participants will vape a 50/50 mixture of high marijuana (\>10% THC) and regular cigarette (25.94 mg/g nicotine content)

Group VIII: High marijuana and Very Low Nicotine Content cigarette Experimental Treatment 3 Interventions

Participants will vape a 50/50 mixture of high marijuana (\>10% THC) and Very Low Nicotine Content cigarette (0.42 mg/g nicotine content)

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7364845/

Cannabis Use Is Associated With Increased Risk ... Cannabis use was associated with increased cigarette smoking initiation, decreased smoking cessation, and increased smoking relapse among adults in the United ...

2. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7412a1.htm

Routes of Marijuana Use — Behavioral Risk Factor... Among the 15.3% of respondents who reported current marijuana use, smoking was the most frequent route (79.4%), followed by eating (41.6%), ...

3. truthinitiative.org truthinitiative.org/research-resources/substance-use/link-between-cannabis-and-tobacco

The link between cannabis and tobacco The most frequent and consistent route of cannabis use among adolescents was smoking (99%), followed by edible use (61%), and then vaping (44%) ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030178

Association of Cannabis Use With Cardiovascular ... Cannabis use is associated with adverse cardiovascular outcomes, with heavier use (more days per month) associated with higher odds of adverse outcomes.

5. cancercontrol.cancer.gov cancercontrol.cancer.gov/brp/tcrb/co-use-tobacco-alcohol-cannabis

Co-Use of Tobacco with Alcohol and Cannabis Other research indicates that individuals who smoke cigarettes and use cannabis are less likely to successfully quit smoking (13, 14) and score higher on ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6324384/

Acute Effects of Smoked and Vaporized Cannabis in Healthy ... After inhaling smoked and vaporized cannabis containing 25 mg of THC, participants experienced pronounced drug effects, substantial impairment ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757764/

Cannabis vaping: Understanding the health risks of a ... Cannabis vaping is thought to generate fewer toxic emissions than cannabis smoking, it has been associated with several cases of acute lung injury.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dar.13800

Cannabis vaporisation: Understanding products, devices ... Metered dose inhalers and dried product vaporisers present the lowest safety risk due to a lower risk of toxin exposure and the use of lower ...

9. npr.org npr.org/2025/02/03/nx-s1-5246302/vape-marijuana-weed-pesticides-chemicals

Vaping weed is very popular, but users should be aware it ... Chemicals, pesticides and intense concentrations are all things that may be in the liquid versions of marijuana that are vaporized and ...

10. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038913

Smoking or Vaping Cannabis and Cardiovascular Function This is because cannabis (with increased THC and less cannabidiol content) is believed to potentially induce dangerous cardiovascular effects, ...