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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the drug used in the clinical trial for cannabis and tobacco use?

Research shows that varenicline, a drug used in the trial, helped people quit tobacco more effectively than a placebo, with 46% achieving tobacco abstinence compared to 24% with placebo. Additionally, nabilone, another drug in the trial, reduced cannabis withdrawal symptoms. ^{1 2 3 4 5}

Is vaporized cannabis and nicotine safe for human use?

There is limited safety data on the combined use of vaporized cannabis and nicotine. Cannabis products can interact with other drugs and may cause adverse events, so users should be monitored for potential risks. ^{1 5 6 7 8}

How does the drug Vaporized Cannabis + Nicotine differ from other treatments for cannabis and tobacco use?

This treatment is unique because it involves the simultaneous use of vaporized cannabis and nicotine, which is less common compared to traditional methods that often focus on either substance separately. The combination of these two substances in a vaporized form may offer a novel approach to addressing the co-use of cannabis and tobacco, potentially targeting the specific behaviors and dependencies associated with their concurrent use. ^{1 6 7 9 10}

Research Team

Gideon St. Helen, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Who mixes tobacco with cannabis and does mixing relate to nicotine dependence? [2023]

2. England pubmed.ncbi.nlm.nih.gov

Does cannabis use moderate smoking cessation outcomes in treatment-seeking tobacco smokers? Analysis from a large multi-center trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Varenicline and nabilone in tobacco and cannabis co-users: effects on tobacco abstinence, withdrawal and a laboratory model of cannabis relapse. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Modes of delivery in concurrent nicotine and cannabis use ("co-use") among youth: Findings from the International Tobacco Control (ITC) Survey. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mobile contingency management as an adjunctive treatment for co-morbid cannabis use disorder and cigarette smoking. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Sociodemographic differences in patterns of nicotine and cannabis vaping among US adults. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Flavored Cannabis Use and Cannabis-Tobacco Co-use: Patterns In U.S. States With Legalized Nonmedical Adult Use. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cannabis and Cannabinoids: Kinetics and Interactions. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Clinical correlates of co-occurring cannabis and tobacco use: a systematic review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Use of Inhaled Nicotine and Cannabis Products among Adults Who Vape Both Substances. [2023]