NCT07585006 · Ohio State University Comprehensive Cancer Center
Comparative Evaluation of Nicotine Analogs
(CENA)
What this study is about
This phase I trial compares electronic cigarette (EC) user preferences and smoking behaviors of nicotine analogs to nicotine to improve the understanding of nicotine analog addictiveness. Over the last ten years, EC use has become a major concern due to its increased use among adolescents and young adults.
View original scientific description
This phase I trial compares electronic cigarette (EC) user preferences and smoking behaviors of nicotine analogs to nicotine to improve the understanding of nicotine analog addictiveness. Over the last ten years, EC use has become a major concern due to its increased use among adolescents and young adults. Though progress has been made in regulating nicotine containing products, some companies have shifted toward producing products containing nicotine analogs. ECs are battery-powered electronic devices designed to atomize a nicotine (the poisonous chemical found in tobacco)-containing liquid solution for inhalation in a manner that simulates smoking a tobacco cigarette. When nicotine enters the body, it causes an increased heart rate and use of oxygen by the heart, and a sense of well-being and relaxation. Nicotine analogs are compounds that are similar to nicotine in their chemical structure. Some nicotine analogs have been shown to have nicotine-like effects; however, more research is needed to prove they function similarly to nicotine and/or have similar effects. Comparing EC user preferences and smoking behaviors of nicotine analogs to nicotine may help improve the understanding of nicotine analog addictiveness. Additionally, combustible cigarette smoking is well-known to have deleterious effects on cardiovascular health. High blood pressure is one of the major health consequences of cigarette smoking and can increase the risk of hypertension, heart attack, and stroke. Although ECs have been marketed as a less harmful alternative to cigarette smoking, clinical trials have shown that vaping ECs can also lead to acute increases in blood pressure and heart rate. Nicotine can alter vascular reactivity by promoting the release of vasoconstrictors and suppressing the production of vasodilators. No research has examined how the synthetic nicotine in ECs affects hemodynamics, vascular health, and endothelial function. Assessing acute cardiovascular responses to nicotine analogs is therefore critical to enhancing our understanding of the potential cardiovascular risks associated with vaping ECs containing synthetic nicotine.
Interventions
PROCEDURE
Biospecimen Collection
Undergo urine and blood sample collection
DRUG
Nicotine
Use nicotine EC
DRUG
6-Methyl Nicotine
Use 6-MN EC
DRUG
nicotinamide
Use nicotinamide EC
BEHAVIORAL
Puffing Topography Research
Ancillary studies
OTHER
Survey Administration
Ancillary studies
PROCEDURE
Cardiovascular effects
Cardiovascular effects will be measured using hemodynamic responses (i.e., blood pressure, pulse pressure, mean arterial pressure), arterial stiffness (i.e., central augmentation index), and endothelial function (i.e., plasma levels of endothelin-1, 6-keto-PGF1α, and nitric oxide metabolite).
Primary outcome measures
Nicotine urges/craving (QSU)
Time frame: Before puffing (0 minutes), and at 5, 15, 65, 95, and 125 minutes after the start of the puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)
E-cigarette (EC) urges/craving will be measured with a modified version of the 10-item Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU). Words such as "cigarette" and "smoke" are replaced with words such as "e-cigarette" and "vape." Each of the 10 items is scored on a 7 point Likert scale. Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke; 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 smoke.
Nicotine withdrawal symptoms (MNWS)
Time frame: Before puffing (0 minutes), and at 5, 15, 65, 95, and 125 minutes after the start of the puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)
The 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS) will be used to measure nicotine withdrawal symptoms. Items are rated on a 5-point scale from 0 (none) to 4 (severe) where higher scores indicate a greater experience of withdrawal symptoms.
Economic demand indices (E-CPT)
Time frame: After completion of the 60 minute ad lib puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)
Consumer demand as measured by the E-Cigarette Purchase Task (E-CPT) will be used to measure economic demand. Participants will report the volume (mLs) or puffs of e-liquid they would be willing to purchase and use within 24 hours at a given price, which will incrementally increase from $0 to $1,120.
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
- Aged 21 years or older
- Current adult EC user for at least the past 3 months (confirmed by cotinine testing strip)
- Willing and able to provide informed consent
- Willing to abstain from using any nicotine, tobacco, or marijuana products for 12 or more hours prior to the three lab visits
- Able to read, write, and speak English
Exclusion criteria
- Currently attempting to quit nicotine or tobacco products
- Use of other tobacco or nicotine products \> 10 days in the past month
- Have had a recent cardiac event or distress (defined as occurring within the previous 3 months)
- Have had a recent serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, asthma, or lung cancer) (defined as occurring in the previous 30 days)
- Currently pregnant, planning to become pregnant, or breastfeeding (verified with urine pregnancy test)
Where
- Columbus, Ohio
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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 Jun 26, 2026 · Source of record for eligibility and locations