Manipulating E-Cigarette Nicotine to Promote Public Health
NCT ID: NCT06448351
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2024-05-20
2027-05-20
Brief Summary
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Detailed Description
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I. 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
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 before study visits
* Read and speak English
Exclusion Criteria
* 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
21 Years
65 Years
ALL
Yes
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Theodore Wagener
Principal Investigator
Principal Investigators
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Theodore L Wagener
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2023-05712
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-23143
Identifier Type: -
Identifier Source: org_study_id
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