Clinical trial · Interventional
Manipulating E-Cigarette Nicotine to Promote Public Health
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tobacco-Related Carcinoma | Tobacco-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Carbon Monoxide Measurement | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Vaping session | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (28)
- type
- EXPERIMENTAL
- label
- Phase 1, Arm 1 (High, Nic, S)
- description
- 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).
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Carbon Monoxide Measurement
- Other: Vaping session
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Phase 1, Arm 2 (High, Nic, R/S)
- description
- 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).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available