Actively Recruiting
Manipulating E-Cigarette Nicotine to Promote Public Health
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-05-13
375
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how different characteristics of nicotine in e-cigarettes (ECs) affect addiction potential and health risks. The trial aims to understand how nicotine strength, form, and structure influence the way people use ECs, how the body processes nicotine, and any possible harmful effects. This information may help identify optimal nicotine levels for users and support development of product standards to promote public health. The study has two phases. In Phase 1, participants are randomized to vape one of eight e-liquids that differ by nicotine concentration (20 or 50 mg/g), form, and isomer type. Each session includes a 10-puff vaping period over 5 minutes followed by a 60-minute free puffing session, with 8 lab visits total. Participants practice at home with devices matching the study e-liquids. In Phase 2, participants vape 20 different e-liquids varying in nicotine concentration, free-base nicotine percentage, and isomer type during two visits with multiple 2-puff sessions and washout periods between. Participants attend lab visits for vaping sessions, carbon monoxide testing, and blood and urine sample collection. The study measures nicotine blood levels, metabolism, toxicity, puffing behavior, and subjective responses using questionnaires. The trial monitors effects over up to 2 years. Total participation duration varies by phase. The study includes healthy adult EC users and smokers interested in trying ECs, assessing multiple factors to understand nicotine's impact on use and health.
CONDITIONS
Brief Title
Manipulating E-Cigarette Nicotine to Promote Public Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Current exclusive young adult e-cigarette user for at least the past 3 months between 21-24 years old with no or minimal cigarette smoking history (10 or fewer cigarettes in entire life)
- Current older adult smoker (daily use, 100 or more cigarettes in entire life) aged 25-65 interested in trying an e-cigarette
- Willing to abstain from all nicotine, tobacco, and marijuana for at least 12 hours before Study 1 visits and 2 hours before Study 2 visits
- Able to read, write, and speak English
You will not qualify if you...
- Currently trying to quit nicotine or tobacco products
- Currently pregnant, planning to become pregnant, or breastfeeding
- For ages 21-24, use of tobacco products other than e-cigarettes (more than 10 cigarettes, cigars, smokeless tobacco, or recent hookah use)
- Diagnosed lung diseases such as asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- New or unstable cardiovascular disease diagnosed within the past 3 months
- Use of medications that induce CYP2A6 enzyme, including rifampicin, dexamethasone, phenobarbital, and other anticonvulsants
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 lab visits, each lasting up to 4 hours
Participants vape eight different study e-liquids in randomized order during lab visits. Each visit includes a 10-puff vaping session over 5 minutes followed by a 60-minute washout and then an ad libitum puffing session over 60 minutes. Participants receive a pre-filled study device for home practice corresponding to the next e-liquid. Blood and urine samples are collected, and carbon monoxide testing is performed at each visit.
8 lab visits (in-person)
Duration - 2 lab visits, each lasting up to 5 hours
Participants vape twenty different study e-liquids in randomized order during two lab visits. Each visit lasts up to 5 hours and includes vaping sessions with 10 e-liquids. Each vaping session involves 2 puffs followed by a 20-minute washout. Blood and urine samples are collected, and carbon monoxide testing is performed during these visits.
2 lab visits (in-person)
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
28
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