Comparative Evaluation of Nicotine Analogs (CENA)

May 27, 2026 updated by: Theodore Wagener, Ohio State University Comprehensive Cancer Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the subjective effects and behavioral economic demand of 6-methyl nicotine (6-MN) and nicotinamide.

II. To assess the use topography of 6-MN and nicotinamide. III. To conduct exploratory pharmacokinetics of 6-MN and nicotinamide. IV. To assess the acute effects of 6-MN and nicotinamide on cardiovascular health.

OUTLINE: Participants are randomized to 1 of 6 intervention sequences.

SEQUENCE 1:

VISIT 1: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

SEQUENCE 2:

VISIT 1: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

SEQUENCE 3:

VISIT 1: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

SEQUENCE 4:

VISIT 1: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

SEQUENCE 5:

VISIT 1: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

SEQUENCE 6:

VISIT 1: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

Additionally, all patients undergo urine sample collection during screening and blood sample collection on study.

Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.

After completion of study intervention, participants are followed up at 4 and 12 weeks.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Theodore L. Wagener, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1 (nicotine, 6-MN, nicotinamide)

VISIT 1: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Nicotine
Use nicotine EC
Other Names:
  • (-)-Nicotine
  • NIC
Drug: 6-Methyl Nicotine
Use 6-MN EC
Other Names:
  • 6-MN
  • Nixodine
  • Nixotine
Drug: nicotinamide
Use nicotinamide EC
Other Names:
  • NAM
  • Nixodine
  • Nixamide
Behavioral: Puffing Topography Research
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).
Experimental: Sequence 2 (nicotine, nicotinamide, 6-MN)

VISIT 1: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Nicotine
Use nicotine EC
Other Names:
  • (-)-Nicotine
  • NIC
Drug: 6-Methyl Nicotine
Use 6-MN EC
Other Names:
  • 6-MN
  • Nixodine
  • Nixotine
Drug: nicotinamide
Use nicotinamide EC
Other Names:
  • NAM
  • Nixodine
  • Nixamide
Behavioral: Puffing Topography Research
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).
Experimental: Sequence 3 (nicotinamide, 6-MN, nicotine)

VISIT 1: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Nicotine
Use nicotine EC
Other Names:
  • (-)-Nicotine
  • NIC
Drug: 6-Methyl Nicotine
Use 6-MN EC
Other Names:
  • 6-MN
  • Nixodine
  • Nixotine
Drug: nicotinamide
Use nicotinamide EC
Other Names:
  • NAM
  • Nixodine
  • Nixamide
Behavioral: Puffing Topography Research
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).
Experimental: Sequence 4 (nicotinamide, nicotine, 6-MN)

VISIT 1: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Nicotine
Use nicotine EC
Other Names:
  • (-)-Nicotine
  • NIC
Drug: 6-Methyl Nicotine
Use 6-MN EC
Other Names:
  • 6-MN
  • Nixodine
  • Nixotine
Drug: nicotinamide
Use nicotinamide EC
Other Names:
  • NAM
  • Nixodine
  • Nixamide
Behavioral: Puffing Topography Research
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).
Experimental: Sequence 5 (6-MN, nicotine, nicotinamide)

VISIT 1: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Nicotine
Use nicotine EC
Other Names:
  • (-)-Nicotine
  • NIC
Drug: 6-Methyl Nicotine
Use 6-MN EC
Other Names:
  • 6-MN
  • Nixodine
  • Nixotine
Drug: nicotinamide
Use nicotinamide EC
Other Names:
  • NAM
  • Nixodine
  • Nixamide
Behavioral: Puffing Topography Research
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).
Experimental: Sequence 6 (6-MN, nicotinamide, nicotine)

VISIT 1: Participants take 1 puff of 6-MN EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use 6-MN EC as much or as little as they like over 1 hour.

VISIT 2: Participants take 1 puff of nicotinamide EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotinamide EC as much or as little as they like over 1 hour.

VISIT 3: Participants take 1 puff of nicotine EC every 30 seconds over 5 minutes for a total of 10 puffs in the absence of unacceptable toxicity. Sixty minutes later, participants use nicotine EC as much or as little as they like over 1 hour.

Patients undergo urine sample collection during screening and blood sample collection on study. Among enrolled current EC users, cardiovascular measurements and biochemical analyses of endothelial function will be conducted in a subset of the participants.
Other: Survey Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo urine and blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Drug: Nicotine
Use nicotine EC
Other Names:
  • (-)-Nicotine
  • NIC
Drug: 6-Methyl Nicotine
Use 6-MN EC
Other Names:
  • 6-MN
  • Nixodine
  • Nixotine
Drug: nicotinamide
Use nicotinamide EC
Other Names:
  • NAM
  • Nixodine
  • Nixamide
Behavioral: Puffing Topography Research
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use topography: Inter-puff-interval
Time Frame: 60 minute 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 average time between each puff for each participant, in seconds.
60 minute 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)
Use topography: Puffing duration
Time Frame: 60 minute 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)
Average puff duration for each participant, in seconds.
60 minute 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)
Use topography: Total puff volume
Time Frame: 60 minute 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 total volume of all puffs taken for each participant, in mL.
60 minute 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)
Nicotine/Nicotine analog pharmacokinetics: Cmax
Time Frame: Immediately before puffing (0 minutes), and at 5, 15, 65, 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)
Maximum blood concentration of nicotine/nicotine analog.
Immediately before puffing (0 minutes), and at 5, 15, 65, 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)
Nicotine/Nicotine analog pharmacokinetics: Tmax
Time Frame: Immediately before puffing (0 minutes), and at 5, 15, 65, 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)
Time to maximum blood concentration of nicotine/nicotine analog.
Immediately before puffing (0 minutes), and at 5, 15, 65, 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)
Heart rate
Time Frame: Immediately before puffing (0 minutes), and at 5, 15, 65, 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)
Heart rate
Immediately before puffing (0 minutes), and at 5, 15, 65, 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)
Modified EC evaluation questionnaire (mCEQ)
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)
The modified EC Evaluation Questionnaire (mCEQ) will be used to measure sensory effects, affective responses, and other subjective responses (e.g., reward, satisfaction). The 12-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). 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, an craving reduction.
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)
Cardiovascular responses
Time Frame: Immediately before puffing (0 minutes), and at 5 minutes after the end of standardized vaping 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)
Hemodynamics and arterial stiffness
Immediately before puffing (0 minutes), and at 5 minutes after the end of standardized vaping 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)
Endothelial function
Time Frame: Immediately before puffing (0 minutes) and 15 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)
Endothelial biomarker levels will be quantified from blood samples collected immediately before puffing.
Immediately before puffing (0 minutes) and 15 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Theodore L Wagener, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-25353
  • NCI-2026-00343 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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