Cigarette Smoking-Related CarcinomaNCT05455086

Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study

A study testing Cigarette Smoking, Computed Tomography and Positron Emission Tomography in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical trial studies the effect of free-base compared with nicotine salt based e-liquids on electronic cigarette (EC) puffing behavior, abuse liability, and deposition and absorption of nicotine in the respiratory tract and rate of uptake in the brain in current EC smokers. Read more about this study

Who is it for?: Ages 21 to 50 years
Conditions the study is for: Cigarette Smoking-Related Carcinoma
What is being tested?: Cigarette Smoking, Computed Tomography and Positron Emission Tomography
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 23 Mar 2022to 26 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 6 months (confirmed by NicAlert saliva testing strip)
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

Who cannot join

Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET

Read the detailed description

PRIMARY OBJECTIVES:

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: Cigarette Smoking-Related Carcinoma
Being tested: Cigarette Smoking, Computed Tomography, Positron Emission Tomography, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cigarette SmokingBehavioural
Receive 1 puff of tobacco flavored protonated e-liquid
Cigarette SmokingBehavioural
Receive 1 puff of unflavored protonated e-liquid
Cigarette SmokingBehavioural
Receive 1 puff of tobacco flavored unprotonated cigarette
Cigarette SmokingBehavioural
Receive 1 puff of unfavored unprotonated cigarette
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT05455086
Study group	Role	What they receive
Arm I (pronated e-liquid, unprotonated e-liquid	Experimental	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 Receives: Behavioral: Cigarette Smoking; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Questionnaire Administration
Arm II (unprotonated e-liquid, protonated e-liquid	Active comparator	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. Receives: Behavioral: Cigarette Smoking; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

PET/CT Imaging of the Head
Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the brain with total absorbed dose (TAD) of [11C]nicotine.
Measured: 1.5 hours
PET/CT Imaging of the Chest
Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the respiratory tract with total absorbed dose (TAD) of [11C]nicotine.
Measured: 1.5 hours
Puff Volume (mL)
Puffing topography data was captured by the study e-cigarette to determine the puff volume.
Measured: approx. 30 minutes
Puff Duration (s)
Puffing topography data was captured by the study e-cigarette to determine the puff duration.
Measured: approx. 30 minutes
Age of First Tobacco Use
Age of first use will be assessed using the tobacco use history questionnaire.
Measured: approx. 5 minutes
Years of Tobacco Use
Years of tobacco use will be assessed using the tobacco use history questionnaire.
Measured: approx. 5 minutes
Years of Regular Use of Nicotine/Tobacco Products
Years of regular use of nicotine/tobacco products will be assessed using the tobacco history questionnaire
Measured: approx. 5 minutes
Past 30 Day Use of Nicotine/Tobacco Products
Days used in the past 30 days of nicotine/tobacco products including cigars, cigarillos, little cigars, pipe tobacco, chewing tobacco, snuff, snus, EC/vape/mod/APV/e-hookah, and hookah tobacco.
Measured: approx. 5 minutes
Modified Cigarette Evaluation Questionnaire (mCEQ)
12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 0 (not at all) to 6 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale.
Measured: approx. 5 minutes
Drug Effects Liking Questionnaire (DEQ)
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of the study products. Five visual analog scale items ranging from 0 (not at all) to 100 (extremely) assessed wanting to vape the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. Higher scores indicate greater liking.
Measured: approx. 5 minutes
Modified Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate e-cigarette smoking-related items (All I want right now is an e-cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke an e-cigarette; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to vape.
Measured: aprox. 5 minutes
Minnesota Nicotine Withdrawal Scale
Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving.
Measured: approx. 5 minutes
Exhaled Breath Carbon Monoxide (CO)
Exhaled breath carbon monoxide was collected before each scan with a handheld electrochemical device.
Measured: approx. 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 202226 Jun 2023

First posted13 Jul 2022
Study start23 Mar 2022
Primary completion26 Jun 2023
Study completion26 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05455086
Sponsor's protocol ID: OSU-21069
Other IDs: NCI-2021-05882
Status last verified: Mar 2025
First submitted: 20 Sep 2021
Last updated: 24 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cigarette Smoking-Related Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET
ClinicalTrials.gov ID: NCT05455086
Acronym / sponsor ID: OSU-21069
Conditions: Cigarette Smoking-Related Carcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Study start: 23 Mar 2022 (actual)
Primary completion: 26 Jun 2023 (actual)
Study completion: 26 Jun 2023 (actual)
First posted: 13 Jul 2022 (actual)
Results: Posted 24 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

ARM II:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (pronated e-liquid, unprotonated e-liquid	Experimental	Behavioral: Cigarette Smoking, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Questionnaire AdministrationVISIT 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
Arm II (unprotonated e-liquid, protonated e-liquid	Active comparator	Behavioral: Cigarette Smoking, Procedure: Computed Tomography, Procedure: Positron Emission Tomography, Other: Questionnaire AdministrationVISIT 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.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 6 months (confirmed by NicAlert saliva testing strip)
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

Key exclusion criteria (6 listed)

Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cigarette SmokingReceive 1 puff of tobacco flavored protonated e-liquid	Behavioural	Arm I (pronated e-liquid, unprotonated e-liquid, Arm II (unprotonated e-liquid, protonated e-liquid
Cigarette SmokingReceive 1 puff of unflavored protonated e-liquid	Behavioural	Arm I (pronated e-liquid, unprotonated e-liquid, Arm II (unprotonated e-liquid, protonated e-liquid
Cigarette SmokingReceive 1 puff of tobacco flavored unprotonated cigarette	Behavioural	Arm I (pronated e-liquid, unprotonated e-liquid, Arm II (unprotonated e-liquid, protonated e-liquid
Cigarette SmokingReceive 1 puff of unfavored unprotonated cigarette	Behavioural	Arm I (pronated e-liquid, unprotonated e-liquid, Arm II (unprotonated e-liquid, protonated e-liquid
Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT	Procedure or surgery	Arm I (pronated e-liquid, unprotonated e-liquid, Arm II (unprotonated e-liquid, protonated e-liquid
Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT	Procedure or surgery	Arm I (pronated e-liquid, unprotonated e-liquid, Arm II (unprotonated e-liquid, protonated e-liquid
Questionnaire AdministrationAncillary studies	Other	Arm I (pronated e-liquid, unprotonated e-liquid, Arm II (unprotonated e-liquid, protonated e-liquid

Primary outcome

PET/CT Imaging of the Head
Time frame: 1.5 hours
Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the brain with total absorbed dose (TAD) of [11C]nicotine.
PET/CT Imaging of the Chest
Time frame: 1.5 hours
Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the respiratory tract with total absorbed dose (TAD) of [11C]nicotine.
Puff Volume (mL)
Time frame: approx. 30 minutes
Puffing topography data was captured by the study e-cigarette to determine the puff volume.
Puff Duration (s)
Time frame: approx. 30 minutes
Puffing topography data was captured by the study e-cigarette to determine the puff duration.
Age of First Tobacco Use
Time frame: approx. 5 minutes
Age of first use will be assessed using the tobacco use history questionnaire.
Years of Tobacco Use
Time frame: approx. 5 minutes
Years of tobacco use will be assessed using the tobacco use history questionnaire.
Years of Regular Use of Nicotine/Tobacco Products
Time frame: approx. 5 minutes
Years of regular use of nicotine/tobacco products will be assessed using the tobacco history questionnaire
Past 30 Day Use of Nicotine/Tobacco Products
Time frame: approx. 5 minutes
Days used in the past 30 days of nicotine/tobacco products including cigars, cigarillos, little cigars, pipe tobacco, chewing tobacco, snuff, snus, EC/vape/mod/APV/e-hookah, and hookah tobacco.
Modified Cigarette Evaluation Questionnaire (mCEQ)
Time frame: approx. 5 minutes
12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 0 (not at all) to 6 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale.
Drug Effects Liking Questionnaire (DEQ)
Time frame: approx. 5 minutes
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of the study products. Five visual analog scale items ranging from 0 (not at all) to 100 (extremely) assessed wanting to vape the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. Higher scores indicate greater liking.
Modified Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Time frame: aprox. 5 minutes
Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate e-cigarette smoking-related items (All I want right now is an e-cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke an e-cigarette; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to vape.
Minnesota Nicotine Withdrawal Scale
Time frame: approx. 5 minutes
Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving.
Exhaled Breath Carbon Monoxide (CO)
Time frame: approx. 5 minutes
Exhaled breath carbon monoxide was collected before each scan with a handheld electrochemical device.

Results and safety

Results posted to the registry on 24 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Protonated E-liquid, Unprotonated E-liquid)	12	12
Arm II (Unprotonated E-liquid, Protonated E-liquid)	8	8

Primary outcome: PET/CT Imaging of the Head

Time frame: 1.5 hours. Mean (Standard Deviation). Unit: %TAD/kg

Measure	Protonated E-liquid n = 17	Unprotonated E-liquid n = 17
Value	2.81 (0.92)	2.40 (0.62)

Population analysed: Scan data from 3 participants was insufficient for calculating TAD and are not included in the statistics presented here, these participants were used for protocol optimizations.

Primary outcome: PET/CT Imaging of the Chest

Time frame: 1.5 hours. Mean (Standard Deviation). Unit: %TAD/kg

Measure	Protonated E-liquid n = 17	Unprotonated E-liquid n = 17
Upper Respiratory Tract	6.18 (2.17)	11.62 (3.17)
Lower Respiratory Tract	10.35 (3.49)	5.53 (0.81)

Population analysed: Scan data from 3 participants was insufficient for calculating TAD and are not included in the statistics presented here, these participants were used for protocol optimizations.

Primary outcome: Puff Volume (mL)

Time frame: approx. 30 minutes. Mean (Standard Deviation). Unit: mL

Measure	Protonated E-liquid n = 18	Unprotonated E-liquid n = 19
Value	79.35 (72.75)	73.76 (70.82)

Population analysed: Puffing topography was not able to be recorded for 2 participants while sampling the Protonated e-liquid and 1 participant while sampling the Unprotonated e-liquid.

Primary outcome: Puff Duration (s)

Time frame: approx. 30 minutes. Mean (Standard Deviation). Unit: seconds

Measure	Protonated E-liquid n = 18	Unprotonated E-liquid n = 19
Value	2.87 (1.43)	2.82 (1.61)

Population analysed: Puffing topography was not able to be recorded for 2 participants while sampling the Protonated e-liquid and 1 participant while sampling the Unprotonated e-liquid.

Adverse events

Time frame: Over 3 study visits, up to 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Protonated E-liquid	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Unprotonated E-liquid	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Theodore L Wagener, PhD principal investigator

Ohio State University Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PET/CT Imaging of the Head (time frame: 1.5 hours). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.