Tobacco-Related CarcinomaNCT06448351
Manipulating E-Cigarette Nicotine to Promote Public Health
A study testing Biospecimen Collection, Carbon Monoxide Measurement and Vaping session in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco-Related Carcinoma
- What is being tested?
- Biospecimen Collection, Carbon Monoxide Measurement and Vaping session
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current exclusive young adult EC user for at least the past 3 months (confirmed by cotinine testing strip) between 21-24 years old with no/minimal history of smoking cigarettes (≤ 10 cigarettes in entire life)
- Current older adult smoker (daily use, ≥ 100 cigarettes in entire life) aged 25-65 with interest in trying an EC
- Willing to abstain from all nicotine, tobacco products, and marijuana for at least 12 hours for Study 1 and 2 hours for Study 2 before study visits
- Read, write, and speak English
Who cannot join
- Currently attempting to quit nicotine or tobacco products
- Currently pregnant (will be verified with urine pregnancy test), planning to become pregnant, or breastfeeding
- If age 21-24 years old AND use of any tobacco products other than ECs (use of >10 cigarettes in entire life; use of >10 traditional cigars, cigarillos, or filtered cigars in entire life; use of smokeless tobacco products >10 times in entire life; or hookah in the last 30 days).
- Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- New or unstable cardiovascular disease diagnosed within the past 3 months
- Use of medications that are inducers of CYP2A6 enzyme such as rifampicin, dexamethasone, phenobarbital, and other anti-convulsion drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Theodore L. Wagener, PhD, 844-744-2447, ccc-tobacco@osumc.edu
Theodore L. Wagener, PhD
About this study
This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the pharmacological, metabolic, and behavioral impact of nicotine dimensions. (Study 1) II. Assess the toxicity resulting from different nicotine dimension combinations. (Study 1) III. Across ecologically valid nicotine concentrations and isomer ratios, determine free-base (FB) nicotine fractions with minimal appeal to young adult EC users but sufficient appeal to smokers. (Study 2)
OUTLINE:
Phase 1 (STUDY 1): Participants are randomized to the order of 8 e-liquid combinations varying in nicotine concentration, form, and isomer.
Participants participate in a 10-puff vaping session over 5 minutes with a study e-liquid using the study EC device followed by a 60 minute washout period and then an ad libitum puffing session over 60 minutes at each lab visit. Patients are also given a new pre-filled study device corresponding to the study e-liquid they will use for the subsequent visit to practice at home. Puffing sessions continue with a new study e-liquid at each of the 8 lab visits lasting up to 4 hours each. Participants also undergo carbon monoxide (CO) testing and blood and urine sample collection on study.
Phase 2 (STUDY 2): Participants are randomized to the order of 20 e-liquid combinations varying in concentration, FB fractions, and isomer.
Participants will take part in a 2-puff vaping session with each of the 20 study e-liquids using the study EC device with a 20-minute washout period between each vaping session. Vaping sessions are grouped into two visits, each lasting up to 5 hours and consisting of 10 e-liquids. Participants also undergo CO testing and blood and urine sample collection on study.
- Conditions
- Tobacco-Related Carcinoma
- Being tested
- Biospecimen Collection, Carbon Monoxide Measurement, Vaping session, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and urine sample collection
Carbon Monoxide MeasurementProcedure or surgery
Also called Carbon Monoxide, CMONOX
Undergo CO test
Vaping sessionOther
Also called Vaping e-liquid
Sample study e-liquids in vaping sessions at research lab with e-cig study device
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, Arm 1 (High, Nic, S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 1, Arm 2 (High, Nic, R/S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 1, Arm 3 (Low, Nic, S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 1, Arm 4 (Low, Nic, R/S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 1, Arm 5 (High, NicH+, S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 1, Arm 6 (High, NicH+, R/S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 1, Arm 7 (Low, NicH+, S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 1, Arm 8 (Low, NicH+, R/S) | Experimental | Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 1 (High, 5%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 2 (High, 5%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 3 (Low, 5%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 4 (Low, 5%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 5 (High, 25%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 6 (High, 25%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 7 (Low, 25%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 8 (Low, 25%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 9 (High, 45%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 10 (High, 45%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 11 (Low, 45%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 12 (Low, 45%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 13 (High , 65%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 14 (High , 65%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 15 (Low, 65%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 16 (Low, 65%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 17 (High, 85%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 18 (High, 85%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 19 (Low, 85%, S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
| Phase 2, Arm 20 (Low, 85%, R/S) | Experimental | Participants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. Receives: Procedure: Biospecimen Collection; Procedure: Carbon Monoxide Measurement; Other: Vaping session; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine pharmacokinetics: Maximum nicotine blood level (Cmax) (Study 1)
Blood nicotine samples will be assayed using liquid chromatography tandem mass spectrometry (LC-MS/MS) with deuterated internal standards.
Measured: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Nicotine pharmacokinetics: Time to maximum blood level (Tmax) (Study 1)
Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.
Measured: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Nicotine pharmacokinetics: Area under the curve (AUC) (Study 1)
Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.
Measured: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Nicotine metabolism (Study 1)
The rate of nicotine metabolism will be assessed using the standard method of nicotine metabolite ration (NMR) = hydroxycotinine/cotinine, modified to reflect stereoselective metabolism. Plasma concentration of cotinine, and hydroxycotinine will be measured by chiral LC-MS/MS based on previous methods and quantified using the ratio of metabolites to internal standards.
Measured: At 60 minutes after the start of each puffing session
Reactive oxygen species (ROS) (Study 1)
The recorded puffing topographies will be sent to the analytical lab for "puff playback" generation of EC aerosols and quantification of ROS. We will use an acellular ROS assay previously developed by our team as a generic toxicity assessment method.
Measured: Up to 2 years
Nicotine toxicity measures (Study 1)
Will be assessed by carbonyl yields reported as ug/session or ug/puff or normalized per nicotine yield for a head-to-head comparison between different nicotine conditions.
Measured: Up to 2 years
In vitro nicotine toxicity measures: Cell cycle and proliferation (Study 1)
Will be assessed by cell cycle and proliferationg.
Measured: Up to 2 years
In vitro nicotine toxicity measures: Cytotoxicity (Study 1)
Will be assessed by cytotoxicity, senescence.
Measured: Up to 2 years
In vitro nicotine toxicity measures: Senescence (Study 1)
Will be assessed by senescence.
Measured: Up to 2 years
In vitro nicotine toxicity measures: RNA sequencing (Study 1)
Will be assessed by RNA sequencing.
Measured: Up to 2 years
Nicotine yield (Study 1)
Using a dilute-and-shoot method developed by our team, nicotine yield in EC aerosol will be quantified using the "playback" technique (i.e., use topography collected from participants to machine-generate EC aerosols) and GC-MS method, developed by our group to minimize the PG/VG interference not addressed by other methods.
Measured: Up to 2 years
Modified Cigarette Evaluation Questionnaire (mCEQ)(Study 1)
The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses. The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, and craving reduction.
Measured: Study visits 2 through 9
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette") for EC users. This is a 10-item measure where participants rate smoking/vaping-related items 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/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.
Measured: Study visits 2 through 9
Drug Effects/Liking Questionnaire (DEQ)(Study 1)
Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)
Measured: Study visits 2 through 9
Minnesota Nicotine Withdrawal Scale (MNWS)(Study 1)
Asses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).
Measured: Study visits 2 through 9
Puffing topography: Puff count (Study1)
Puff count will be measured.
Measured: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: Average puff duration (Study1)
Average puff duration will be measured.
Measured: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: inter-puff interval (Study1)
Inter-puff interval will be measured.
Measured: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: Flow rate (Study1)
Flow rate will be measured.
Measured: 60 minute puffing session at each of the 8 study lab visits
Puffing topography: Volume (Study1)
Puff volume will be measured.
Measured: 60 minute puffing session at each of the 8 study lab visits
General Labeled Magnitude Scale (gLMS) (Study 2)
Complete the General Labeled Magnitude Scale (gLMS) after each condition. Scores range from 0 "No Sensation" to 100 "Strongest Imaginable".
Measured: 1 six hour lab visit
Labeled Hedonic Scale (LHS) (Study 2)
Complete the Labeled Hedonic Scale (LHS) after each condition. Scores range from -100 "Most Disliked Imaginable" to 100 "Most Liked Imaginable".
Measured: 1 six hour lab visit
Sensory Attributes (Study 2)
Rate sensory attributes (smoothness, harshness, sweetness, bitterness) on a 100-unit visual analog scale after each condition.
Measured: 1 six hour lab visit
Overall acceptance: Industry-designed Thermometer Rating Scale (Study 2)
Complete a tobacco industry-designed thermometer rating scale of overall acceptance after each condition. Ratings range from 0 "the very worst" to 100 "the very best", with 50 indicating "indifferent".
Measured: 1 six hour lab visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start20 May 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco-Related CarcinomaStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Wagener, Ohio State University Comprehensive Cancer Center
- Investigators
- Theodore L Wagener, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448351
- Sponsor's protocol ID
- OSU-23143
- Other IDs
- NCI-2023-05712
- Status last verified
- Aug 2026
- First submitted
- 22 May 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulating E-Cigarette Nicotine to Promote Public Health
- ClinicalTrials.gov ID
- NCT06448351
- Acronym / sponsor ID
- OSU-23143
- Conditions
- Tobacco-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.
Detailed description
PRIMARY OBJECTIVES:
- Assess the pharmacological, metabolic, and behavioral impact of nicotine dimensions. (Study 1) II. Assess the toxicity resulting from different nicotine dimension combinations. (Study 1) III. Across ecologically valid nicotine concentrations and isomer ratios, determine free-base (FB) nicotine fractions with minimal appeal to young adult EC users but sufficient appeal to smokers. (Study 2)
OUTLINE:
Phase 1 (STUDY 1): Participants are randomized to the order of 8 e-liquid combinations varying in nicotine concentration, form, and isomer.
Participants participate in a 10-puff vaping session over 5 minutes with a study e-liquid using the study EC device followed by a 60 minute washout period and then an ad libitum puffing session over 60 minutes at each lab visit. Patients are also given a new pre-filled study device corresponding to the study e-liquid they will use for the subsequent visit to practice at home. Puffing sessions continue with a new study e-liquid at each of the 8 lab visits lasting up to 4 hours each. Participants also undergo carbon monoxide (CO) testing and blood and urine sample collection on study.
Phase 2 (STUDY 2): Participants are randomized to the order of 20 e-liquid combinations varying in concentration, FB fractions, and isomer.
Participants will take part in a 2-puff vaping session with each of the 20 study e-liquids using the study EC device with a 20-minute washout period between each vaping session. Vaping sessions are grouped into two visits, each lasting up to 5 hours and consisting of 10 e-liquids. Participants also undergo CO testing and blood and urine sample collection on study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 28
| Arm | Type | Receives |
|---|---|---|
| Phase 1, Arm 1 (High, Nic, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 1, Arm 2 (High, Nic, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 1, Arm 3 (Low, Nic, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 1, Arm 4 (Low, Nic, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 1, Arm 5 (High, NicH+, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 1, Arm 6 (High, NicH+, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 1, Arm 7 (Low, NicH+, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 1, Arm 8 (Low, NicH+, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low [20 mg/g] or high [50 mg/g]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine). |
| Phase 2, Arm 1 (High, 5%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 2 (High, 5%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 3 (Low, 5%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 4 (Low, 5%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 5 (High, 25%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 6 (High, 25%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 7 (Low, 25%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 8 (Low, 25%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 9 (High, 45%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 10 (High, 45%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 11 (Low, 45%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 12 (Low, 45%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 13 (High , 65%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 14 (High , 65%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 15 (Low, 65%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 16 (Low, 65%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 17 (High, 85%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 18 (High, 85%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 19 (Low, 85%, S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
| Phase 2, Arm 20 (Low, 85%, R/S) | Experimental | Procedure: Biospecimen Collection, Procedure: Carbon Monoxide Measurement, Other: Vaping session, Other: Survey AdministrationParticipants vape 20 different study e-liquids varying in concentration (low [20 mg/g] or high [50 mg/g]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current exclusive young adult EC user for at least the past 3 months (confirmed by cotinine testing strip) between 21-24 years old with no/minimal history of smoking cigarettes (≤ 10 cigarettes in entire life)
- Current older adult smoker (daily use, ≥ 100 cigarettes in entire life) aged 25-65 with interest in trying an EC
- Willing to abstain from all nicotine, tobacco products, and marijuana for at least 12 hours for Study 1 and 2 hours for Study 2 before study visits
- Read, write, and speak English
Key exclusion criteria (6 listed)
- Currently attempting to quit nicotine or tobacco products
- Currently pregnant (will be verified with urine pregnancy test), planning to become pregnant, or breastfeeding
- If age 21-24 years old AND use of any tobacco products other than ECs (use of >10 cigarettes in entire life; use of >10 traditional cigars, cigarillos, or filtered cigars in entire life; use of smokeless tobacco products >10 times in entire life; or hookah in the last 30 days).
- Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- New or unstable cardiovascular disease diagnosed within the past 3 months
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood and urine sample collection | Procedure or surgery | Phase 1, Arm 1 (High, Nic, S), Phase 1, Arm 2 (High, Nic, R/S), Phase 1, Arm 3 (Low, Nic, S), Phase 1, Arm 4 (Low, Nic, R/S), Phase 1, Arm 5 (High, NicH+, S), Phase 1, Arm 6 (High, NicH+, R/S), Phase 1, Arm 7 (Low, NicH+, S), Phase 1, Arm 8 (Low, NicH+, R/S), Phase 2, Arm 1 (High, 5%, S), Phase 2, Arm 10 (High, 45%, R/S), Phase 2, Arm 11 (Low, 45%, S), Phase 2, Arm 12 (Low, 45%, R/S), Phase 2, Arm 13 (High , 65%, S), Phase 2, Arm 14 (High , 65%, R/S), Phase 2, Arm 15 (Low, 65%, S), Phase 2, Arm 16 (Low, 65%, R/S), Phase 2, Arm 17 (High, 85%, S), Phase 2, Arm 18 (High, 85%, R/S), Phase 2, Arm 19 (Low, 85%, S), Phase 2, Arm 2 (High, 5%, R/S), Phase 2, Arm 20 (Low, 85%, R/S), Phase 2, Arm 3 (Low, 5%, S), Phase 2, Arm 4 (Low, 5%, R/S), Phase 2, Arm 5 (High, 25%, S), Phase 2, Arm 6 (High, 25%, R/S), Phase 2, Arm 7 (Low, 25%, S), Phase 2, Arm 8 (Low, 25%, R/S), Phase 2, Arm 9 (High, 45%, S) |
| Carbon Monoxide MeasurementAlso: Carbon Monoxide, CMONOXUndergo CO test | Procedure or surgery | Phase 1, Arm 1 (High, Nic, S), Phase 1, Arm 2 (High, Nic, R/S), Phase 1, Arm 3 (Low, Nic, S), Phase 1, Arm 4 (Low, Nic, R/S), Phase 1, Arm 5 (High, NicH+, S), Phase 1, Arm 6 (High, NicH+, R/S), Phase 1, Arm 7 (Low, NicH+, S), Phase 1, Arm 8 (Low, NicH+, R/S), Phase 2, Arm 1 (High, 5%, S), Phase 2, Arm 10 (High, 45%, R/S), Phase 2, Arm 11 (Low, 45%, S), Phase 2, Arm 12 (Low, 45%, R/S), Phase 2, Arm 13 (High , 65%, S), Phase 2, Arm 14 (High , 65%, R/S), Phase 2, Arm 15 (Low, 65%, S), Phase 2, Arm 16 (Low, 65%, R/S), Phase 2, Arm 17 (High, 85%, S), Phase 2, Arm 18 (High, 85%, R/S), Phase 2, Arm 19 (Low, 85%, S), Phase 2, Arm 2 (High, 5%, R/S), Phase 2, Arm 20 (Low, 85%, R/S), Phase 2, Arm 3 (Low, 5%, S), Phase 2, Arm 4 (Low, 5%, R/S), Phase 2, Arm 5 (High, 25%, S), Phase 2, Arm 6 (High, 25%, R/S), Phase 2, Arm 7 (Low, 25%, S), Phase 2, Arm 8 (Low, 25%, R/S), Phase 2, Arm 9 (High, 45%, S) |
| Vaping sessionAlso: Vaping e-liquidSample study e-liquids in vaping sessions at research lab with e-cig study device | Other | Phase 1, Arm 1 (High, Nic, S), Phase 1, Arm 2 (High, Nic, R/S), Phase 1, Arm 3 (Low, Nic, S), Phase 1, Arm 4 (Low, Nic, R/S), Phase 1, Arm 5 (High, NicH+, S), Phase 1, Arm 6 (High, NicH+, R/S), Phase 1, Arm 7 (Low, NicH+, S), Phase 1, Arm 8 (Low, NicH+, R/S), Phase 2, Arm 1 (High, 5%, S), Phase 2, Arm 10 (High, 45%, R/S), Phase 2, Arm 11 (Low, 45%, S), Phase 2, Arm 12 (Low, 45%, R/S), Phase 2, Arm 13 (High , 65%, S), Phase 2, Arm 14 (High , 65%, R/S), Phase 2, Arm 15 (Low, 65%, S), Phase 2, Arm 16 (Low, 65%, R/S), Phase 2, Arm 17 (High, 85%, S), Phase 2, Arm 18 (High, 85%, R/S), Phase 2, Arm 19 (Low, 85%, S), Phase 2, Arm 2 (High, 5%, R/S), Phase 2, Arm 20 (Low, 85%, R/S), Phase 2, Arm 3 (Low, 5%, S), Phase 2, Arm 4 (Low, 5%, R/S), Phase 2, Arm 5 (High, 25%, S), Phase 2, Arm 6 (High, 25%, R/S), Phase 2, Arm 7 (Low, 25%, S), Phase 2, Arm 8 (Low, 25%, R/S), Phase 2, Arm 9 (High, 45%, S) |
| Survey AdministrationAncillary studies | Other | Phase 1, Arm 1 (High, Nic, S), Phase 1, Arm 2 (High, Nic, R/S), Phase 1, Arm 3 (Low, Nic, S), Phase 1, Arm 4 (Low, Nic, R/S), Phase 1, Arm 5 (High, NicH+, S), Phase 1, Arm 6 (High, NicH+, R/S), Phase 1, Arm 7 (Low, NicH+, S), Phase 1, Arm 8 (Low, NicH+, R/S), Phase 2, Arm 1 (High, 5%, S), Phase 2, Arm 10 (High, 45%, R/S), Phase 2, Arm 11 (Low, 45%, S), Phase 2, Arm 12 (Low, 45%, R/S), Phase 2, Arm 13 (High , 65%, S), Phase 2, Arm 14 (High , 65%, R/S), Phase 2, Arm 15 (Low, 65%, S), Phase 2, Arm 16 (Low, 65%, R/S), Phase 2, Arm 17 (High, 85%, S), Phase 2, Arm 18 (High, 85%, R/S), Phase 2, Arm 19 (Low, 85%, S), Phase 2, Arm 2 (High, 5%, R/S), Phase 2, Arm 20 (Low, 85%, R/S), Phase 2, Arm 3 (Low, 5%, S), Phase 2, Arm 4 (Low, 5%, R/S), Phase 2, Arm 5 (High, 25%, S), Phase 2, Arm 6 (High, 25%, R/S), Phase 2, Arm 7 (Low, 25%, S), Phase 2, Arm 8 (Low, 25%, R/S), Phase 2, Arm 9 (High, 45%, S) |
Primary outcome
Nicotine pharmacokinetics: Maximum nicotine blood level (Cmax) (Study 1)
Time frame: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Blood nicotine samples will be assayed using liquid chromatography tandem mass spectrometry (LC-MS/MS) with deuterated internal standards.
Nicotine pharmacokinetics: Time to maximum blood level (Tmax) (Study 1)
Time frame: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.
Nicotine pharmacokinetics: Area under the curve (AUC) (Study 1)
Time frame: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session
Blood nicotine samples will be assayed using LC-MS/MS with deuterated internal standards.
Nicotine metabolism (Study 1)
Time frame: At 60 minutes after the start of each puffing session
The rate of nicotine metabolism will be assessed using the standard method of nicotine metabolite ration (NMR) = hydroxycotinine/cotinine, modified to reflect stereoselective metabolism. Plasma concentration of cotinine, and hydroxycotinine will be measured by chiral LC-MS/MS based on previous methods and quantified using the ratio of metabolites to internal standards.
Reactive oxygen species (ROS) (Study 1)
Time frame: Up to 2 years
The recorded puffing topographies will be sent to the analytical lab for "puff playback" generation of EC aerosols and quantification of ROS. We will use an acellular ROS assay previously developed by our team as a generic toxicity assessment method.
Nicotine toxicity measures (Study 1)
Time frame: Up to 2 years
Will be assessed by carbonyl yields reported as ug/session or ug/puff or normalized per nicotine yield for a head-to-head comparison between different nicotine conditions.
In vitro nicotine toxicity measures: Cell cycle and proliferation (Study 1)
Time frame: Up to 2 years
Will be assessed by cell cycle and proliferationg.
In vitro nicotine toxicity measures: Cytotoxicity (Study 1)
Time frame: Up to 2 years
Will be assessed by cytotoxicity, senescence.
In vitro nicotine toxicity measures: Senescence (Study 1)
Time frame: Up to 2 years
Will be assessed by senescence.
In vitro nicotine toxicity measures: RNA sequencing (Study 1)
Time frame: Up to 2 years
Will be assessed by RNA sequencing.
Nicotine yield (Study 1)
Time frame: Up to 2 years
Using a dilute-and-shoot method developed by our team, nicotine yield in EC aerosol will be quantified using the "playback" technique (i.e., use topography collected from participants to machine-generate EC aerosols) and GC-MS method, developed by our group to minimize the PG/VG interference not addressed by other methods.
Modified Cigarette Evaluation Questionnaire (mCEQ)(Study 1)
Time frame: Study visits 2 through 9
The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses. The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, and craving reduction.
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Time frame: Study visits 2 through 9
Smoking and vaping urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form with a modified version (replacing the word "cigarette" with "e-cigarette") for EC users. This is a 10-item measure where participants rate smoking/vaping-related items 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/vape; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 for each of the factors with higher scores indicating greater craving to smoke/vape.
Drug Effects/Liking Questionnaire (DEQ)(Study 1)
Time frame: Study visits 2 through 9
Assess the desire and liking of products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Scores range from 1 to 5 with higher scores indicating greater strength (effect from smoking cigarettes/vaping e-cigarettes) or liking (liking of effect from smoking cigarettes/vaping e-cigarettes)
Minnesota Nicotine Withdrawal Scale (MNWS)(Study 1)
Time frame: Study visits 2 through 9
Asses Nicotine withdrawal and smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal (MNWS) or more craving to smoke (MNWS Craving).
Puffing topography: Puff count (Study1)
Time frame: 60 minute puffing session at each of the 8 study lab visits
Puff count will be measured.
Puffing topography: Average puff duration (Study1)
Time frame: 60 minute puffing session at each of the 8 study lab visits
Average puff duration will be measured.
Puffing topography: inter-puff interval (Study1)
Time frame: 60 minute puffing session at each of the 8 study lab visits
Inter-puff interval will be measured.
Puffing topography: Flow rate (Study1)
Time frame: 60 minute puffing session at each of the 8 study lab visits
Flow rate will be measured.
Puffing topography: Volume (Study1)
Time frame: 60 minute puffing session at each of the 8 study lab visits
Puff volume will be measured.
General Labeled Magnitude Scale (gLMS) (Study 2)
Time frame: 1 six hour lab visit
Complete the General Labeled Magnitude Scale (gLMS) after each condition. Scores range from 0 "No Sensation" to 100 "Strongest Imaginable".
Labeled Hedonic Scale (LHS) (Study 2)
Time frame: 1 six hour lab visit
Complete the Labeled Hedonic Scale (LHS) after each condition. Scores range from -100 "Most Disliked Imaginable" to 100 "Most Liked Imaginable".
Sensory Attributes (Study 2)
Time frame: 1 six hour lab visit
Rate sensory attributes (smoothness, harshness, sweetness, bitterness) on a 100-unit visual analog scale after each condition.
Overall acceptance: Industry-designed Thermometer Rating Scale (Study 2)
Time frame: 1 six hour lab visit
Complete a tobacco industry-designed thermometer rating scale of overall acceptance after each condition. Ratings range from 0 "the very worst" to 100 "the very best", with 50 indicating "indifferent".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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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.
Ohio State University Comprehensive Cancer Center
Columbus, United States
Theodore L Wagener 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?
A study testing Biospecimen Collection, Carbon Monoxide Measurement and Vaping session in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine pharmacokinetics: Maximum nicotine blood level (Cmax) (Study 1) (time frame: Immediately before puffing (-5 minutes), and at 5, 15, 60, and 120 minutes after the start of the puffing session). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.