Recruiting

E-Cigarette Nicotine

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06448351

Conditions

Tobacco-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Carbon Monoxide Measurement

Vaping session

Survey Administration

Study Details

Brief 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 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.

Conditions

Tobacco-Related Carcinoma

Study ID

NCT06448351

Start date

May 20, 2024

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

375 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Phase 1, Arm 1 (High, Nic, S)

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).

experimental: Phase 1, Arm 2 (High, Nic, R/S)

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).

experimental: Phase 1, Arm 3 (Low, Nic, S)

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).

experimental: Phase 1, Arm 4 (Low, Nic, R/S)

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).

experimental: Phase 1, Arm 5 (High, NicH+, S)

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).

experimental: Phase 1, Arm 6 (High, NicH+, R/S)

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).

experimental: Phase 1, Arm 7 (Low, NicH+, S)

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).

experimental: Phase 1, Arm 8 (Low, NicH+, R/S)

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).

experimental: Phase 2, Arm 1 (High, 5%, S)

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.

experimental: Phase 2, Arm 2 (High, 5%, R/S)

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.

experimental: Phase 2, Arm 3 (Low, 5%, S)

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.

experimental: Phase 2, Arm 4 (Low, 5%, R/S)

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.

experimental: Phase 2, Arm 5 (High, 25%, S)

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.

experimental: Phase 2, Arm 6 (High, 25%, R/S)

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.

experimental: Phase 2, Arm 7 (Low, 25%, S)

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.

experimental: Phase 2, Arm 8 (Low, 25%, R/S)

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.

experimental: Phase 2, Arm 9 (High, 45%, S)

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.

experimental: Phase 2, Arm 10 (High, 45%, R/S)

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.

experimental: Phase 2, Arm 11 (Low, 45%, S)

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.

experimental: Phase 2, Arm 12 (Low, 45%, R/S)

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.

experimental: Phase 2, Arm 13 (High , 65%, S)

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.

experimental: Phase 2, Arm 14 (High , 65%, R/S)

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.

experimental: Phase 2, Arm 15 (Low, 65%, S)

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.

experimental: Phase 2, Arm 16 (Low, 65%, R/S)

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.

experimental: Phase 2, Arm 17 (High, 85%, S)

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.

experimental: Phase 2, Arm 18 (High, 85%, R/S)

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.

experimental: Phase 2, Arm 19 (Low, 85%, S)

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.

experimental: Phase 2, Arm 20 (Low, 85%, R/S)

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.

Interventions

Biospecimen Collection

Undergo blood and urine sample collection

Carbon Monoxide Measurement

Undergo CO test

Vaping session

Sample study e-liquids in vaping sessions at research lab with e-cig study device

Survey Administration

Ancillary studies

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 ]
  • 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 ]
  • 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 ]
  • Nicotine metabolism (Study 1) [ Time Frame: At 60 minutes after the start of each puffing session ]
  • Reactive oxygen species (ROS) (Study 1) [ Time Frame: Up to 2 years ]
  • Nicotine toxicity measures (Study 1) [ Time Frame: Up to 2 years ]
  • In vitro nicotine toxicity measures: Cell cycle and proliferation (Study 1) [ Time Frame: Up to 2 years ]
  • In vitro nicotine toxicity measures: Cytotoxicity (Study 1) [ Time Frame: Up to 2 years ]
  • In vitro nicotine toxicity measures: Senescence (Study 1) [ Time Frame: Up to 2 years ]
  • In vitro nicotine toxicity measures: RNA sequencing (Study 1) [ Time Frame: Up to 2 years ]
  • Nicotine yield (Study 1) [ Time Frame: Up to 2 years ]
  • Modified Cigarette Evaluation Questionnaire (mCEQ)(Study 1) [ Time Frame: Study visits 2 through 9 ]
  • Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU) [ Time Frame: Study visits 2 through 9 ]
  • Drug Effects/Liking Questionnaire (DEQ)(Study 1) [ Time Frame: Study visits 2 through 9 ]
  • Minnesota Nicotine Withdrawal Scale (MNWS)(Study 1) [ Time Frame: Study visits 2 through 9 ]
  • Puffing topography: Puff count (Study1) [ Time Frame: 60 minute puffing session at each of the 8 study lab visits ]
  • Puffing topography: Average puff duration (Study1) [ Time Frame: 60 minute puffing session at each of the 8 study lab visits ]
  • Puffing topography: inter-puff interval (Study1) [ Time Frame: 60 minute puffing session at each of the 8 study lab visits ]
  • Puffing topography: Flow rate (Study1) [ Time Frame: 60 minute puffing session at each of the 8 study lab visits ]
  • Puffing topography: Volume (Study1) [ Time Frame: 60 minute puffing session at each of the 8 study lab visits ]
  • General Labeled Magnitude Scale (gLMS) (Study 2) [ Time Frame: 1 six hour lab visit ]
  • Labeled Hedonic Scale (LHS) (Study 2) [ Time Frame: 1 six hour lab visit ]
  • Sensory Attributes (Study 2) [ Time Frame: 1 six hour lab visit ]
  • Overall acceptance: Industry-designed Thermometer Rating Scale (Study 2) [ Time Frame: 1 six hour lab visit ]

Central Contacts and Locations

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Theodore L. Wagener, PhD

844-744-2447ccc-tobacco@osumc.edu

Principal Investigator:

Theodore L. Wagener, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-14.