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

Sponsor
University of Southern California (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03750825
Collaborator
University of California (Other)
150
1
3
12.9
11.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NIDA Standard Research E-cigarette (SREC)
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Are Smokers Switching to Vaping at Lower Risk for Cancer?
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vapers

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

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

No Intervention: Smokers

Smokers will continue to smoke.

No Intervention: Nonsmokers non-vapers

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

Outcome Measures

Primary Outcome Measures

  1. Genetic changes [3 months]

    Number and location of DNA damage

  2. Epigenetic changes [3 months]

    Number of epigenetic marks

Secondary Outcome Measures

  1. Gene expression [Every 2 weeks for 3 months]

    Relative gene expression

  2. DNA methylation [Every 2 weeks for 3 months]

    Pattern and distribution of aberrant DNA methylation

  3. Histone modifications [Every 2 weeks for 3 months]

    Pattern and distribution of histone marks

  4. Mutation [Every 2 weeks for 3 months]

    Frequency and location of mutations

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern California, Health Sciences Campus Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California
  • University of California

Investigators

  • Principal Investigator: Ahmad Besaratinia, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmad Besaratinia, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier:
NCT03750825
Other Study ID Numbers:
  • HS-18-00744
First Posted:
Nov 23, 2018
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Ahmad Besaratinia, Associate Professor, University of Southern California

Study Results

No Results Posted as of Dec 3, 2021