NCT06448351 · Ohio State University Comprehensive Cancer Center
Manipulating E-Cigarette Nicotine to Promote Public Health
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood and urine sample collection
PROCEDURE
Carbon Monoxide Measurement
Undergo CO test
OTHER
Vaping session
Sample study e-liquids in vaping sessions at research lab with e-cig study device
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
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".
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2026 · Source of record for eligibility and locations