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

• ClinicalTrials.gov Identifier: NCT03750825
• Recruitment Status: Not yet recruiting
• First Posted: November 23, 2018
• Last Update Posted: December 3, 2021
• Sponsor: University of Southern California
• Collaborator: University of California
• Information provided by (Responsible Party): Ahmad Besaratinia, University of Southern California

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
Cigarette Smoking	Device: NIDA Standard Research E-cigarette (SREC)	Not Applicable

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 (Clinical Trial)
• Estimated 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?
• Estimated Study Start Date: June 1, 2022
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: June 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 [ Time Frame: 3 months ]
   Number and location of DNA damage
2. Epigenetic changes [ Time Frame: 3 months ]
   Number of epigenetic marks

Secondary Outcome Measures :

1. Gene expression [ Time Frame: Every 2 weeks for 3 months ]
   Relative gene expression
2. DNA methylation [ Time Frame: Every 2 weeks for 3 months ]
   Pattern and distribution of aberrant DNA methylation
3. Histone modifications [ Time Frame: Every 2 weeks for 3 months ]
   Pattern and distribution of histone marks
4. Mutation [ Time Frame: Every 2 weeks for 3 months ]
   Frequency and location of mutations

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts

Contact: Ahmad Besaratinia, Ph.D.; 3234420088; besarati@med.usc.edu

Contact: Stella Tommasi, Ph.D.; 3234427753; tommasi@med.usc.edu

Locations

United States, California

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

More Information

• Responsible Party: Ahmad Besaratinia, Associate Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT03750825
• Other Study ID Numbers: HS-18-00744
• First Posted: November 23, 2018
• Last Update Posted: December 3, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

• 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, University of Southern California:

Electronic Nicotine Delivery System