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Vaporized Cannabis + Nicotine for Cannabis and Tobacco Use (CANNIC Trial)

Phase 2

Waitlist Available

Led By Gideon St Helen

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7 and day 8

Awards & highlights

CANNIC Trial Summary

This trial tests how smoking cannabis and tobacco together affects the body, to inform public health consequences. #marijuana #tobacco #pharmacology

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include typical reactions to cannabis such as increased heart rate, dry mouth, red eyes, short-term memory loss or paranoia; and from nicotine like dizziness, nausea or increased blood pressure. The combined use might amplify these effects but this will be closely monitored.

CANNIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7 and day 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7 and day 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 and day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Peak plasma concentration of nicotine

Change in peak plasma concentration of THC

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC)

Cardiovascular effects among dosages using heart rate as a measure

Change in subjective effects scores using the Marijuana Cravings Questionnaire (MCQ)

CANNIC Trial Design

8Treatment groups

Experimental Treatment

Group I: Regular cigarette onlyExperimental Treatment2 Interventions

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

Group II: Placebo marijuana and regular cigaretteExperimental Treatment3 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 cigaretteExperimental Treatment3 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 cigaretteExperimental Treatment3 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 cigaretteExperimental Treatment3 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 onlyExperimental Treatment2 Interventions

Participants will vape high marijuana (>10% THC)

Group VII: High marijuana and regular cigaretteExperimental Treatment3 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 cigaretteExperimental Treatment3 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cannabis

2014

Completed Phase 3

~810

Nicotine

2005

Completed Phase 4

~2980

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,545 Total Patients Enrolled

28 Trials studying Cannabis Use

6,109 Patients Enrolled for Cannabis Use

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,540 Total Patients Enrolled

1 Trials studying Cannabis Use

148 Patients Enrolled for Cannabis Use

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,423 Total Patients Enrolled

1 Trials studying Cannabis Use

110 Patients Enrolled for Cannabis Use

Media Library

Medium marijuana and Very Low Nicotine Content cigarette Clinical Trial Eligibility Overview. Trial Name: NCT05999383 — Phase 2

Cannabis Use Research Study Groups: Medium marijuana and Very Low Nicotine Content cigarette, Medium marijuana and regular cigarette, High marijuana and regular cigarette, Regular cigarette only, High marijuana only, Placebo marijuana and regular cigarette, Placebo marijuana and Very Low Nicotine Content cigarette, High marijuana and Very Low Nicotine Content cigarette

Cannabis Use Clinical Trial 2023: Medium marijuana and Very Low Nicotine Content cigarette Highlights & Side Effects. Trial Name: NCT05999383 — Phase 2

Medium marijuana and Very Low Nicotine Content cigarette 2023 Treatment Timeline for Medical Study. Trial Name: NCT05999383 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve minors or is the participant pool restricted to adults?

"This research initiative is seeking individuals who have attained legal adulthood yet remain under the age of 65."

Answered by AI

What kind of effects can the use of Medium marijuana and regular cigarettes have on individuals?

"Our assessment of the safety profile of medium marijuana and conventional cigarettes is a 2, owing to evidence that suggests these substances are not harmful but no studies have indicated efficacy."

Answered by AI

Do I satisfy the qualifications necessary to partake in this research?

"Those wishing to join the clinical trial must have tetrahydrocannabinol levels in their system and be between 21 and 65 years old. A total of 48 enrollees will be accepted into this research study."

Answered by AI

Are there any current vacancies for participants in this research project?

"Unfortunately, the information posted on clinicaltrials.gov confirms that this trial is not presently enrolling patients. This study was initially published on October 31st 2023 and underwent its last update on August 11th 2023. Nevertheless, there are 180 other studies actively recruiting individuals at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

2023. "Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05999383.