Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)

University of Southern California

Status: Active, not recruiting

Conditions: Cigarette Smoking

Treatments: Device: NIDA Standard Research E-cigarette (SREC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03750825

HS-18-00744

Details and patient eligibility

About

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.

Full description

Electronic cigarettes (e-cig) are increasingly popular among adult smokers and adolescent never smokers. Chemical analyses of e-cig vapor and liquid have shown the presence of many of the same carcinogens as those found in cigarette smoke, albeit in generally lower concentrations. However, the carcinogenic potential of e-cig has not been investigated in e-cig users (otherwise known as 'vapers'). The investigators will investigate the cancer-causing potential of e-cig use as compared to cigarette smoking by quantifying molecular changes linked to risk of cancer in smokers who switch to e-cig use vs. those who maintain their smoking habits. Leveraging a source population for ongoing studies on e-cig, the investigators will recruit smokers who are interested in switching to e-cig use, and two control groups of non-vapers, including smokers and nonsmokers who do not intend to change their smoking and nonsmoking status, respectively (n = 50, each group). Smokers consenting to switch completely to e-cig will be assigned to a 3-month intervention with a standard e-cig with fully described product characteristics. Control groups will maintain their smoking/nonsmoking habits during the intervention. At weekly intervals, the investigators will verify participants' compliance through personal interviews, CO breath tests, cotinine quantification, and vaping/smoking topography measurements. The investigators will use a non-invasive brushing technique to collect oral cells from the inside of the cheeks of all participants at baseline and every 2 weeks, afterwards. 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

Vapers

Experimental group

Description:

Smokers will switch to NIDA Standard Research E-cigarette (SREC).

Treatment:

Device: NIDA Standard Research E-cigarette (SREC)

Smokers

No Intervention group

Description:

Smokers will continue to smoke.

Nonsmokers non-vapers

No Intervention group

Description:

Control nonsmokers non-vapers will continue to refrain from smoking or vaping.