Clinical trial · Interventional
Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)
Are Smokers Switching to Vaping at Lower Risk for Cancer?
- 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 project will address a growing public health concern, namely, the health risks or benefits of e-cig use relative to cigarette smoking. The investigators will use biomarkers of early effects of relevance to cancer to determine the carcinogenic potential of e-cig use relative to cigarette smoking in oral epithelium, which is a target tissue for smoking-associated cancer. The study population will consist of one group of smokers who are interested in switching to e-cig use (Grp 1), one group of smokers who do not intend to change their smoking habits (Grp 2), and one group of non-users who would like to maintain their nonsmoking non-vaping status (Grp 3); The total number of participants in this project is 150 (n = 50, each group). The investigators will use an integrative 'multi-omics' approach complemented with single-locus/gene validation analyses to detect temporal changes in the genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants as the intervention progresses.
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 |
|---|---|---|---|
| Cigarette Smoking | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NIDA Standard Research E-cigarette (SREC) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vapers
- description
- Smokers will switch to NIDA Standard Research E-cigarette (SREC).
- interventionNames
- Device: NIDA Standard Research E-cigarette (SREC)
- type
- NO_INTERVENTION
- label
- Smokers
- description
- Smokers will continue to smoke.
- type
- NO_INTERVENTION
- label
- Nonsmokers non-vapers
- description
- Control nonsmokers non-vapers will continue to refrain from smoking or vaping.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Being male or female between the ages of 22-55; * Being able to read and write in English and understand and give informed consent; * Giving consent to strictly follow the study protocol throughout the study; * Not planning to move, take an extended vacation, or undergo surgery during the study; * Reporting smoking of \> 5 manufactured cigarettes per day for at least 1 year (applicable to participants who will undergo intervention with e-cig (Grp 1) or continue to smoke (Grp 2) only); and * Presenting with an expired air CO measurement of \> 7 parts per million (ppm) at baseline (applicable to participants who will undergo intervention with e-cig (Grp 1) or continue to smoke (Grp 2) only). Exclusion Criteria: * Having oral infection/inflammation, gum disease, dental decay, immune system disorders, diabetes, respiratory diseases (e.g., asthma), or kidney diseases; * Having any unstable or significant medical condition (e.g., symptomatic heart conditions) in the past 12 months ; * Having body mass index \< 18 kg/m2 or \> 40 kg/m2 * Being pregnant or having a baby in the past 12 months; * Having uncontrolled mental illness or substance abuse (e.g., alcoholism) or inpatient treatment for those conditions in the past 12 months; * Having used recreational or illicit drugs in the past 3 months; * Having used any medication known to induce/inhibit CYP450 2A6 enzyme; * Having any known allergy to propylene glycol/vegetable glycerin (applicable participants who will undergo intervention with e-cig (Grp 1) only); and * Having another member of household participating in the study.
References
Publications (0)
Data not yet available