PET/CT Imaging for Nicotine Distribution from E-Cigarettes

Overseen By Michael V Knopp, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ohio State University

Must be taking: E-cigarettes

Must not be taking: Tranquilizers, Antipsychotics, Antidepressants, Anticonvulsants

Disqualifiers: Heart disease, Hypertension, Diabetes, 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: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how nicotine from e-cigarettes spreads throughout the body using advanced imaging technology. Researchers aim to observe nicotine's movement through the mouth and lungs after vaping and determine the smallest dose needed for clear images. Participants will join either a full study with radiation or a dress rehearsal without it. Daily e-cigarette users with a nicotine strength over 6 mg/ml, who can abstain from nicotine for 4 hours, are suitable candidates. As a Phase 4 trial, this research provides insights into how an already FDA-approved treatment benefits more patients, offering valuable information for e-cigarette users.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes people who use psychiatric medications like tranquilizers, antipsychotics, and antidepressants, as well as medications that affect nicotine metabolism, such as rifampicin and dexamethasone.

What is the safety track record for C-11 labeled nicotine?

Research has shown that using a special type of nicotine, called C-11 labeled nicotine, in PET/CT scans helps scientists understand how nicotine moves through the body when someone uses an e-cigarette. The C-11 label is slightly radioactive, allowing clear visualization of this movement.

In past studies, participants generally tolerated this method well. The main concern is radiation exposure, but the amount used is very low and carefully controlled. The radiation from C-11 fades quickly, enhancing safety for participants.

Participants in similar studies have not reported any serious side effects, indicating that this method is generally safe for human trials. However, as with any research, minor risks may exist, and these will be explained in detail during the study's consent process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses PET/CT imaging with C-11 labeled nicotine to explore how nicotine from e-cigarettes is distributed in the body. This approach is unique because it allows scientists to visualize and track nicotine distribution in real-time, providing insights that current methods can't offer. Understanding this distribution can help improve e-cigarette safety and efficacy, and potentially lead to better nicotine delivery systems.

What evidence suggests that this methodology is effective for evaluating nicotine distribution from e-cigarettes?

This trial will use PET/CT imaging to study nicotine distribution from e-cigarettes. Research has shown that nicotine can be tracked in the body using this special imaging technique. Participants in the "Full Study - Radiation" arm will receive C-11 labeled nicotine, which reveals how nicotine moves and where it goes after e-cigarette use. PET imaging with C-11 labeled nicotine quickly captures nicotine's effects on the brain. This technique helps understand nicotine's spread in the body and the amount needed for clear images. These findings suggest that PET/CT imaging with C-11 labeled nicotine could effectively study nicotine use from e-cigarettes. ^{3 4 6 7 8}

Who Is on the Research Team?

Michael V Knopp, MD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who regularly use e-cigarettes with nicotine strength above 6mg/ml and can abstain from tobacco/nicotine for 4 hours before imaging. It's not for pregnant women, prisoners, those unable to consent or lie flat during scans, people with unstable medical conditions or psychiatric disorders, users of certain medications including CYP2A6 inducers, non-English speakers, and anyone using other tobacco products.

Inclusion Criteria

abstinent from any tobacco/nicotine use for 4 hours prior to imaging

Your past medical history will be considered.

Health medical history

Exclusion Criteria

I am unable to understand and give consent for treatment.

Not a regular user of e-cigarettes

Pregnant or lactating (only excluded from imaging study)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dress Rehearsal

Participants undergo a dress rehearsal to practice the study process without radiation exposure

1 day

1 visit (in-person)

Imaging Study

Participants undergo PET/CT imaging with C11-labeled nicotine to evaluate biodistribution and clearance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse reactions and contacted within 12 to 48 hours after the study

2 days

What Are the Treatments Tested in This Trial?

Interventions

• C-11 labeled nicotine

Trial Overview The study tests how nicotine from e-cigarettes spreads in the body using PET/CT scans with radio-labeled nicotine. Participants will take up to 10 puffs from an e-cigarette containing either a low (3 mCi) or high (9 mCi) dose of C-11 labeled nicotine while undergoing PET/CT imaging to track the distribution and clearance of inhaled nicotine.

How Is the Trial Designed?

Group I: Full Study - Radiation Experimental Treatment 2 Interventions

Group II: Dress Rehearsal Only - No Radiation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/58/3/473

Biodistribution and Radiation Dosimetry of 11 C-Nicotine from ... This study assessed the in vivo distribution of 11 C-nicotine and the absorbed radiation dose from whole-body 11 C-nicotine PET imaging of 11 healthy (5 male ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27660145/

Biodistribution and Radiation Dosimetry of 11C-Nicotine ... This study assessed the in vivo distribution of 11 C-nicotine and the absorbed radiation dose from whole-body 11 C-nicotine PET imaging of 11 healthy (5 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03491059

Feasibility of PET/CT to Detect the Oral/Pulmonary ... During the study, first, S-nicotine will be labeled with C11 and placed in the cartridge of an e-cigarette. The S-nicotine may be given in two different doses.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5484172/

A Programmable Smoke Delivery Device for PET Imaging ... PET imaging with 11C-nicotine-loaded cigarettes is a valuable tool to directly assess fast nicotine kinetics and its neuropharmacological ...

5. researchgate.net researchgate.net/figure/Radiation-Dose-Estimates-for-11-C-Nicotine_tbl2_308570985

Radiation Dose Estimates for 11 C-Nicotine The mean effective dose was 5.2 μSv/MBq in the 370 MBq-injected group and 5.0 μSv/MBq in the 555 MBq-injected group, which were comparable to other 11 C-labeled ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8950566/

E-Cigarette Aerosol Deposition and Disposition of [11C ... This explorative PET/CT study investigated the distribution and deposition of inhaled [ 11 C]nicotine using the myblu TM e-cigarette with two nicotine ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03491059/Prot_000.pdf

THE OHIO STATE UNIVERSITY Institutional Review Board ... After a subject completes an 11C-nicotine vaping session, the PET/CT imaging area will be considered radioactive until 20 half-lives (i.e., 406 ...

8. clinicaltrial.be clinicaltrial.be/en/details/68957?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Feasibility of PET/CT to Detect the Oral/Pulmonary Distri... During the study, first, S-nicotine will be labeled with C11 and placed in the cartridge of an e-cigarette. The S-nicotine may be given in two ...