Manipulating E-Cigarette Nicotine to Promote Public Health
Ohio State University Comprehensive Cancer Center
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.
Description
PRIMARY OBJECTIVES: 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 1…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 before study visits * Read and speak English Exclusion Criteria: * Currently attempting to quit nicotine or tobacco products * Currently pregnant (will be v…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureCarbon Monoxide Measurement
Undergo CO test
- OtherVaping session
Sample study e-liquids in vaping sessions at research lab with e-cig study device
- OtherSurvey Administration
Ancillary studies
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio