Manipulating nicotine in e-cigarettes to improve public health
Manipulating E-Cigarette Nicotine to Promote Public Health
This study tests how different amounts and types of nicotine in e-cigarettes can affect addiction and health risks to help find safer options for smokers and young adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06448351 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how different nicotine concentrations and forms in e-cigarettes affect addiction potential and health risks. Participants will engage in multiple vaping sessions using various e-liquid combinations to assess their pharmacological, metabolic, and behavioral responses. The study aims to identify optimal nicotine levels that minimize appeal to young adult users while still attracting smokers. Additionally, toxicity assessments will be conducted to understand the health implications of these nicotine variations.
Who should consider this trial
Good fit: Ideal candidates include young adult exclusive e-cigarette users aged 21-24 and older adult smokers aged 25-65 interested in trying e-cigarettes.
Not a fit: Patients currently attempting to quit nicotine or tobacco products, or those with significant lung disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of e-cigarette products that reduce addiction potential and health risks for users.
How similar studies have performed: While there is ongoing research into nicotine's effects in e-cigarettes, this specific manipulation of nicotine dimensions is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Theodore L Wagener — Ohio State University Comprehensive Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.