Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use

NCT03491059 | Unknown Phase 4 FDA Drug

• 1 other identifier: SP0232/2017H0463
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

E-cigarette Use

Outcome Measures

Primary Outcomes (3)

• Nicotine biodistribution

  We will measure the intensity of C11 labeled nicotine uptake, measured as SUV in different target and organ systems

  Up to 5 - 10 minutes

• Nicotine uptake

  We will measure the intensity of C11 labeled nicotine uptake, measured as SUV in the oral cavity, lungs, blood stream and brain

  Up to 5 - 10 minutes

• Nicotine clearance

  We will use the intensity of C11 labeled nicotine uptake, measured as SUV in the different target and organ systems in the PET imaging field of view and assess the change of uptake over time as a measure of its elimination

  Up to 5 - 60 minutes

Study Arms (2)

Full Study - Radiation

EXPERIMENTAL

Drug: C-11 labeled nicotine; Radiation: PET/CT imaging

Dress Rehearsal Only - No Radiation

NO INTERVENTION

Interventions

C-11 labeled nicotine DRUG

Participants will vape with e-cigarettes radio-labeled with C-11 nicotine.

Full Study - Radiation

PET/CT imaging RADIATION

After vaping with radio-labeled e-cigarettes, participants will be PET/CT imaged.

Full Study - Radiation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females greater than or equal to 18 years of age
• current regular user of e-cigarettes (use at least once daily for the past 30 days) with nicotine strength \> 6mg/ml
• health medical history
• abstinent from any tobacco/nicotine use for 4 hours prior to imaging

You may not qualify if:

• not a regular user of e-cigarettes
• pregnant or lactating (only excluded from imaging study)
• prisoner
• incapable of giving informed consent
• unable to lie flat on the scanner for extended periods of time
• unstable medical condition like heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, or glaucoma
• prostatic hypertrophy, stroke, or ulcer in past year
• psychiatric conditions such as schizophrenia, adult ADHD, or bipolar disorder
• current or regular use of psychiatric medications such as tranquilizers, antipsychotics, and/or antidepressants
• use of medications that are inducers of CYP2A6 (a nicotine metabolizing enzyme) such as rifampicin, dexamethasone, phenobarbital, and other anti-convulsant drugs
• unable to communicate in English
• current use of smokeless tobacco, tobacco cigarettes (5 and fewer a day)
• occasional use of pipes is permitted if subject abstains for the week prior to the study
• older than 80 years

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Michael V Knopp, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: April 9, 2018
• Study Start: February 16, 2018
• Primary Completion: December 31, 2024
• Study Completion: February 16, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)