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

NCT03750825 | Active Not Recruiting DMC FDA Device

• 1 other identifier: HS-18-00744
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cigarette Smoking

Keywords

Electronic Nicotine Delivery System

Outcome Measures

Primary Outcomes (2)

• Genetic changes

  Number and location of DNA damage

  3 months

• Epigenetic changes

  Number of epigenetic marks

  3 months

Secondary Outcomes (4)

• Gene expression

  Every 2 weeks for 3 months

• DNA methylation

  Every 2 weeks for 3 months

• Histone modifications

  Every 2 weeks for 3 months

• Mutation

  Every 2 weeks for 3 months

Study Arms (3)

Vapers

EXPERIMENTAL

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

Device: NIDA Standard Research E-cigarette (SREC)

Smokers

NO INTERVENTION

Smokers will continue to smoke.

Nonsmokers non-vapers

NO INTERVENTION

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

Interventions

NIDA Standard Research E-cigarette (SREC) DEVICE

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

Vapers

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• University of California: collaborator

Study Sites (1)

University of Southern California, Health Sciences Campus

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Ahmad Besaratinia

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 23, 2018
• Study Start: December 1, 2021
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)