Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study
NCT ID: NCT05455086
Last Updated: 2025-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2022-03-23
2023-06-26
Brief Summary
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Detailed Description
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I. To examine the influence of nicotine form on puffing behavior and abuse liability.
II. To evaluate the influence of nicotine form and concentration on nicotine distribution in the brain and respiratory tract.
OUTLINE:
VISIT 1: Patients sample 4-liquids to determine whether they can vape the unflavored e-liquid without coughing
Patients are randomized to 1 of 2 arms.
ARM I:
VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 minutes (min) head and 5 min chest positron emission tomography (PET)/computed tomography (CT) and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.
VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest
ARM II:
VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest.
VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Arm I (pronated e-liquid, unprotonated e-liquid
VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET?CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.
VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest
Cigarette Smoking
Receive 1 puff of tobacco flavored protonated e-liquid
Cigarette Smoking
Receive 1 puff of unflavored protonated e-liquid
Cigarette Smoking
Receive 1 puff of tobacco flavored unprotonated cigarette
Cigarette Smoking
Receive 1 puff of unfavored unprotonated cigarette
Computed Tomography
Undergo PET/CT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Arm II (unprotonated e-liquid, protonated e-liquid
VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest.
VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.
Cigarette Smoking
Receive 1 puff of tobacco flavored protonated e-liquid
Cigarette Smoking
Receive 1 puff of unflavored protonated e-liquid
Cigarette Smoking
Receive 1 puff of tobacco flavored unprotonated cigarette
Cigarette Smoking
Receive 1 puff of unfavored unprotonated cigarette
Computed Tomography
Undergo PET/CT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Interventions
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Cigarette Smoking
Receive 1 puff of tobacco flavored protonated e-liquid
Cigarette Smoking
Receive 1 puff of unflavored protonated e-liquid
Cigarette Smoking
Receive 1 puff of tobacco flavored unprotonated cigarette
Cigarette Smoking
Receive 1 puff of unfavored unprotonated cigarette
Computed Tomography
Undergo PET/CT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between 21-50 years old
* Willing to provide informed consent and abstain from all tobacco and nicotine use for at least 12 hours prior to visits 2 and 3
* Willing to participate in 3 laboratory visits
* Read and speak English
* If utilizing study provided rideshare services, will need to live within 20 miles of Wake Forest University
Exclusion Criteria
* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* History of cardiac event or distress within the past 3 months
* Currently pregnant (as indicated by urine pregnancy test at the start of each laboratory visit), planning to become pregnant, or breastfeeding (women only)
* Use of other tobacco products (e.g., cigarette, cigar, etc.) \> 5 days in the past month
* Currently engaging in a tobacco product cessation attempt
21 Years
50 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Theodore Wagener
Principal Investigator
Principal Investigators
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Theodore L Wagener, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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The Jamesline
Other Identifiers
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NCI-2021-05882
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-21069
Identifier Type: -
Identifier Source: org_study_id
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