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

2 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators aim to (1) establish a methodology for the evaluation of the biodistribution of radio-labeled nicotine following e-cigarette use, (2) determine the oral/pulmonary distribution of nicotine following e-cigarette use, and (3) determine the lowest required dose using the new digital PET/CT technology to provide detailed or accurate oral/pulmonary distribution data following e-cigarette use. Potential participants will be identified using advertisements such as brochures and online social media postings. After participants are identified, their eligibility will be determined using survey tools. All eligible participants will first have a screening visit at the WCIBMI for study participation. During this initial visit, subjects will be informed about the study in detail, and the relevant consent form will be reviewed and signed. If the participant agrees to participate, they will go through a full dress rehearsal. Up to 10 volunteers will only participate in the dress rehearsal. All other volunteers (30) will have a dress rehearsal without radiation exposure on day 1, and then on a second day, they will participate in the full imaging study using 11C-nicotine. During the imaging study, S-nicotine will be labeled with 11C and placed in the cartridge of an e-cigarette. There will be two dose groups: (A) 3 mCi dosage or (B) 9 mCi doses. The investigators intend to use dose level A; however, if it does not lead to the expected results, an alternate dose level as an option is needed, which is the 9 mCi (B) dose level. Subjects will take a maximum of 10 puffs (1 puff per 30 seconds) from the e-cigarette while positioned in the PET/CT system. Dynamic PET/CT imaging will be performed for a maximum of 60 minutes following inhalation. The subject will be placed in the PET camera in order to generate axial images of the following regions: head/neck (e.g., brain, oral cavity, and throat) and thorax (e.g., trachea, lungs). From the PET/CT images, quantitative radioactivity deposition will be determined, and the biodistribution and uptake/clearance will be evaluated. PET data will be acquired in listmode and subsequently used for simulation to determine the potentially lowest dose feasible using the next generation digital PET/CT technology.

Research Team

Michael V Knopp, MD, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

Your past medical history will be considered.

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

Health medical history

Exclusion Criteria

Occasional use of pipes is permitted if subject abstains for the week prior to the study

Not a regular user of e-cigarettes

Pregnant or lactating (only excluded from imaging study)

Timeline

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

Treatment Details

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.

Participant Groups

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+