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PET/CT Imaging for Nicotine Distribution from E-Cigarettes

Phase 4
Waitlist Available
Led By Michael V Knopp, MD, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current regular user of e-cigarettes (use at least once daily for the past 30 days) with nicotine strength > 6mg/ml
current regular user of e-cigarettes (use at least once daily for the past 30 days) with nicotine strength > 6mg/ml
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 - 60 minutes
Awards & highlights

Study Summary

This trial is testing a new methodology to see how much nicotine from e-cigarettes is absorbed by the body, and to see if a new digital PET/CT technology can provide accurate data on how the nicotine is distributed in the body.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves diagnostic imaging rather than drug treatment, side effects are minimal but may include discomfort from lying still during the scan and potential risks associated with exposure to radiation used in PET/CT imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I use e-cigarettes daily with nicotine strength over 6mg/ml.
Select...
I use e-cigarettes daily with nicotine strength over 6mg/ml.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 - 60 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 - 60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nicotine biodistribution
Nicotine clearance
Nicotine uptake

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Full Study - RadiationExperimental Treatment2 Interventions
Group II: Dress Rehearsal Only - No RadiationActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT imaging
2021
Completed Phase 3
~430

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
827 Previous Clinical Trials
502,749 Total Patients Enrolled
University of CincinnatiLead Sponsor
427 Previous Clinical Trials
634,360 Total Patients Enrolled
Michael V Knopp, MD, PhDPrincipal InvestigatorOhio State University
8 Previous Clinical Trials
502 Total Patients Enrolled

Media Library

C-11 labeled nicotine Clinical Trial Eligibility Overview. Trial Name: NCT03491059 — Phase 4
E-Cigarette Use Research Study Groups: Full Study - Radiation, Dress Rehearsal Only - No Radiation
E-Cigarette Use Clinical Trial 2023: C-11 labeled nicotine Highlights & Side Effects. Trial Name: NCT03491059 — Phase 4
C-11 labeled nicotine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03491059 — Phase 4

Frequently Asked Questions

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

What is the estimated sample size for this clinical trial?

"Affirmative, the information on clinicaltrials.gov declares that this experiment is currently seeking participants. It was posted initially on February 16th 2018 and modified as recently as April 15th 2022. This investigation requires 40 individuals to be enrolled at a single location."

Answered by AI

Has C-11 labeled nicotine been granted permission from the FDA?

"Our esteemed team has evaluated C-11 labeled nicotine's safety to be a 3 out of 3, as this treatment is already approved for use in Phase 4 trials."

Answered by AI

Is it still possible to enroll in this medical research endeavor?

"That is correct. According to information on clinicaltrials.gov, this trial was initially posted on February 16th 2018 and recently updated on April 15th 2022; it seeks 40 participants from one singular medical centre."

Answered by AI

Is geriatric participation permitted in this investigation?

"In accordance with the requirements for this trial, anyone aged 18 or over and under 80 is eligible to participate."

Answered by AI

What criteria must individuals fulfill to be eligible for this clinical trial?

"This trial is attempting to enroll 40 individuals of both genders, aged 18-80 years old. Crucially, prospective participants must have been consuming e-cigarettes for a minimum of 30 days with an nicotine strength greater than 6mg/ml and not consumed any tobacco products within the 4 hours prior to imaging. Additionally, candidates need to display an adequate medical history."

Answered by AI

What prior experiments have explored C-11 labeled nicotine?

"Currently, 71 clinical trials concerning C-11 labeled nicotine are in progress with 5 of them having reached the third phase. Most studies happen to be taking place Green Bay, Wisconsin but 204 other locations also run tests for this compound."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
The Ohio State University Wexner Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use
Michael V Knopp MD PhD 2018. "Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03491059.
~0 spots leftby Dec 2024
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