All Drugs and Chemicals

Nicotine

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

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

NIDA Standard Research E-cigarette (SREC)

Ahmad Besaratinia

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.

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.

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?

There is no plan to make individual participant data (IPD) available to other researchers.

Pattern and distribution of aberrant DNA methylation

Pattern and distribution of histone marks

University of California

University of Southern California

Professor

Central Nervous System Stimulants

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

AT consists of all SC components plus a fully automated smartphone-based JITAI that involves proactive, interactive, and personalized messages, images, or videos in Lao.

SC consists of brief advice to quit smoking delivered by research staff, self-help written materials (the WHO's "A guide for tobacco users to quit" that we have translated to and validated in Lao), and a 2-week supply of NRT (transdermal patches).

Provision of nicotine replacement medications in the form of transdermal patches is important to address nicotine withdrawal/craving for smokers who want to quit. Evidence supporting the safety and efficacy of NRT is vast. The PHS Guideline indicates that use of NRT doubles quit rates and should be considered the minimal standard care. Therefore, we will provide NRT to all participants in both groups in the early cessation phase.

Nicotine patch

Our team has translated and validated the World Health Organization's "A guide for tobacco users to quit" into Lao language for use as the self-help material in this study.

Self-help materials (to support smoking cessation)

The automated treatment(AT) include text messages, images, and videos. The AT content is designed to tap the theoretical mechanisms described in the Phase-Based Model (PBM). That is, treatment content is designed to increase motivation, self-efficacy, use of coping skills, and social support, while reducing nicotine withdrawal symptoms and stress. The AT will begin immediately after enrollment and continue for a 12-week period. The AT approach allows for several levels of personalization for each participant, including tailoring to participants' specific health conditions, individual cessation phases, and participants' self-efficacy level or smoking status in the past week.

Smartphone-based automated treatment for smoking cessation

Thanh C Bui

The parent project (1R21CA253600-01, R21 phase: 9/1/2020-8/31/2022, R33 phase: 9/1/2022-8/31/2025) aims to adapt and evaluate the efficacy of our theoretically and empirically based mobile health (mHealth) technology to help general patients in Lao People's Democratic Republic (Lao PDR) quit smoking cigarettes. This mHealth automated treatment (AT) approach includes a fully automated, interactive, personalized, smartphone-based intervention for behavioral treatment, delivered through our Insight platform.

The purpose of this projects to expand our mHealth-based intervention to address the pressing need for smoking cessation among cancer survivors and their caregivers in Lao PDR. In this project, the investigators will further adapt the AT intervention to ensure that its content is comprehensible and relevant to the target populations (i.e., cancer survivors and caregivers). Then, the investigators will conduct a pilot randomized controlled trial (RCT, N=80) to evaluate the preliminary efficacy of the intervention. Cancer survivors (n=40) and caregivers (n=40) of both sexes who smoke will be identified via medical records at the Setthathirath Hospital (SH) and Lao National Cancer Center (LNCC) and recruited. Similar to the parent project's design, participants will be randomized to 1 of 2 treatment groups: standard care (SC) or AT (20 cancer survivors and 20 caregivers in each group). SC consists of brief advice to quit smoking delivered by research staff, self-help written materials, and a 2-week supply of nicotine patches. AT consists of all SC components plus our fully-automated interactive smartphone-based treatment program, personalized and tailored to cancer survivors or caregivers. The primary RCT outcome is biochemically confirmed self-reported 7-day point prevalence abstinence at 3 months post-study enrollment. The specific aims are as follows:

Aim 1: Evaluate the feasibility of AT in cancer survivors and caregivers. Hypothesis (H1): ≥75% of AT content will be viewed/opened as indicated by digital date/time stamp in Insight.

Aim 2: Evaluate the preliminary efficacy of AT in each cancer survivor/caregiver subgroup. Hypothesis (H2): At the 12-week follow-up, 7-day point prevalence abstinence will be higher in the AT (vs. SC) group.

Stage 1: Further adapt the AT intervention Before conducting the RCT, the investigators will use a multi-step process to adapt our already developed AT intervention for use by the target populations (i.e., cancer survivors and caregivers). These iterative steps include modifying content, user testing and eliciting feedback, and refining. Specifically, the investigators will review all communication messages in the current AT program and modify them to ensure that they are applicable to cancer survivors and caregivers and to both sexes. Then, the investigators will evaluate the AT content applicability, comprehensibility, and linguistic simplicity and clarity with \~10 cancer survivors or caregivers. The investigators will ensure that approximately half of these testing users are women and that the whole testing sample is demographically diverse. Using input and feedback from these testing users, the investigators will revise the AT further if needed. These series of tests and user-feedback sessions to refine the content further and to debug the system will go through an iterative process as needed. AT content taps on theoretical constructs of the Phase-Based Model (PBM)-a theoretical framework specific to smoking cessation used in our JITAI.

Stage 2: The pilot RCT Participant recruitment. Research staff will review medical records of cancer patients receiving care at the 2 hospitals in the past 2 years, screen for their smoking status documented in the records, and contact those who smoked for further screening. To recruit caregivers, research staff will contact random cancer patients who did not smoke and ask if they have a caregiver and if the caregiver smokes. Given the pilot nature of this study, the investigators propose to recruit independent groups of cancer survivors and caregivers who smoke, i.e., no dyads of smokers, to avoid potential interpersonal interactions.

Baseline assessment. Enrolled participants will complete a 45-minute baseline self- or assisted interview, managed and delivered by REDCap. Participants will be randomly assigned to SC or AT by the REDCap randomization module (simple, 1:1). Smartphones will be loaned to participants as needed. All participants will complete a brief training session on smartphone use and the Insight app. The Insight app also includes a help button for instructions on how to use each feature, which participants can review at any time.

Treatment groups. SC consists of brief advice to quit smoking delivered by research staff, self-help written materials (the WHO's "A guide for tobacco users to quit" that the investigators have translated to and validated in Lao), and a 2-week supply of NRT (transdermal patches). AT consists of all SC components plus a fully automated smartphone-based JITAI that involves proactive, interactive, and personalized messages, images, or videos in Lao. Adapted from the parent study and based on the PBM, AT content is designed to increase motivation, self-efficacy, and use of coping skills and reduce nicotine withdrawal symptoms and stress. AT will begin immediately after enrollment and continue for 12 weeks (about 2 messages/images/videos per day, delivered at participants' preferred time). Quit date is set at day 14 post-enrollment for AT and SC participants. JITAI content for AT participants each week will be personalized and tailored to each participant's baseline information (e.g., sex, cancer types, caregiver status, and current health conditions), current PBM phase, and responses to the brief weekly EMAs that drive AT (see Measures). Our AT only targets cigarette smoking because it is the most common type of tobacco used by Lao smokers (95%).

Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos

Deidentified IPD will be shared upon request, with an established data sharing and using agreement.

The primary outcome is smoking status at 3 months post-enrollment. Abstinence will be defined as biochemically confirmed self-reported 7-day point prevalence abstinence with expired CO \<6 ppm.

Participants will be asked to self-report their smoking status (yes/no) in the past week when completing the brief weekly smartphone assessments over a 3-month period, delivered via the Insight-app.

At the 3-month follow-up, participants will self-report their average current numbers of cigarettes smoked per day.

Setthathirath Hospital, Lao PDR

National Cancer Center, Lao PDR

National Center for Laboratory and Epidemiology, Lao PDR

National Tobacco Control Committee, Lao PDR

National Cancer Institute (NCI)

University of Oklahoma

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Stomach Neoplasms

Lung Neoplasms

Lung Diseases

Urinary Bladder Neoplasms

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Chronic Graft Versus Host Disease

Stomach Cancer

Smokers of e-cigarettes containing nicotine only (non smoking traditional cigarettes and inhaling at least 50 puffs per week since six or more months). This group will be further split in the secondary analyses: never or former smokers of traditional cigarettes

Smokers of traditional cigarettes only (smokers of at least one traditional cigarette per day since six or more months). This group will be further split in the secondary analyses: recent and older smokers.

Smokers of both electronic and traditional cigarettes (at least one per day since six or more months). This group will be further split in the secondary analyses: mixed smokers who quit and who did not quit traditional cigarette smoking during follow-up

Lamberto Manzoli, MD, MPH

The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking.

The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit.

Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.

The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study

Multicentric 5-year Follow-up Study to Assess the Efficacy of E-cigarettes as a Tool for Smoking Cessation and to Compare the Risk of Smoking-related Diseases Among Electronic and Traditional Cigarette Smokers, and Smokers of Both.

Percentage of subjects that were current (in TC and Mixed groups) or former (in EC group) smokers reporting sustained smoking abstinence from traditional cigarette smoking at 60 months. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. This outcome will be self-reported and checked using CO analyzer after breath.

Change in the average self-reported number of traditional cigarette smoked per day.

Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once.

Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.

Mean number of hospital admissions for cardiovascular diseases. Each admissions of the same subject will be counted.

Mean number of hospital admissions for cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.

Change in the average quality of life according to EuroQol EQ-D3.

Time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission.

Self-reported side effects as measured by VAS and a structured report form.

Number of months of continued e-cigarette smoking in groups EC and Mixed.

The primary outcome measure is time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission.

Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit.

Percentage of subjects in all groups reporting sustained smoking abstinence from both traditional and electronic cigarette smoking at 12 months. Smoking abstinence is defined as complete abstinence from tobacco or electronic smoking (not even a puff) for the 30 days period prior to the visit.

University of Roma La Sapienza

Catholic University of the Sacred Heart

University of Turin, Italy

University of Catania

Mario Negri Institute for Pharmacological Research

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Associate Professor of Epidemiology and Public Health

Mouth and Tooth Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Neil E Caporaso, M.D.

Background:

- Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They contribute to human health in many ways, including digesting food and balancing hormones. Testing samples from the mouth can show how microbiotas are related to health and disease. However, the microbiota in a person's mouth differs depending on the methods of collection and the part of the mouth that is tested. Understanding what can change the microbiota (including mouth sites, and what a person eats or smokes) will give more information on how to study oral microbiota and smoking-related cancers and other diseases.

Objectives:

* To see how smoking affects the microbiotas in mouth and nose.
* To determine which collection method for mouth specimens should be used for studying microbiota.

Eligibility:

* Individuals at least 18 years of age who have been using tobacco products regularly for at least 5 years.
* Individuals at least 18 years of age who have never smoked.

Design:

* Participants will be screened with a physical exam and medical history.
* Participants will have a dental exam. They will provide a saliva sample. The dentist will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and teeth. The inside of the nose will also be swabbed.
* Participants will also fill out a questionnaire. It will ask about their history of smoking and consumption of alcohol, tea, and coffee. It will also ask about current medications, including antibiotics.

The oral microbial community (the microbiota), is centrally related to nutrition, metabolism, immunity, inflammation, and endocrine balance. Cigarette smoking is associated with serious health outcomes including cancer, cardiovascular disease and chronic lung disease. However, little is known about the relationship between cigarette smoking, oral microbiota and tobacco-related health outcomes. Microbiotas in the different sites of the same oral cavity vary widely. Recent studies indicated that the difference in microbial profiles between buccal mucosa and gingival plaque is as distinct as the difference between tongue and stool. To date, knowledge about the effect of smoking on oral microbiotas is lacking. As an initial step toward understanding the role of the oral microbiota in smoking-related health outcomes, we propose a pilot study to evaluate the effects of cigarette smoking on the microbiotas in buccal rinse obtained from the oral cavity and across 8 different oral cavity sites/niches (saliva, swabs from tongue dorsum, hard palate, buccal mucosa, keratinized gingiva, palatine tonsils, supragingival plaque, subgingival plaque). We will seek to recruit up to 50 volunteers through the Eastman Dental General Dentistry Clinic, Rochester, NY, including 25 current smokers with \> 5 years of smoking history and 25 never smokers as a comparison group. Age-group, gender, and race (Caucasian/African- American) will be matched for the two groups. In each subject, the buccal cell (mouthwash) collection will be collected according to the PLCO buccal cell collection protocol. In addition, collections across 8 different oral cavity sites will be done using a protocol developed for the Human Microbiome Project. These 9 collections will be used for high throughput sequencing of 16S rRNA microbial genes at the Institute of Genome Sciences, University of Maryland School of Medicine. The findings will provide information about the effect of smoking on microbial taxa composition and relative abundance at each collection site. This pilot study will demonstrate the effects of smoking on oral microbiotas across different oral cavity sites and will also demonstrate which oral collection site is most promising for the detailed study about cigarette smoking and oral microbiota. In addition, the data collected will provide a validation framework to use the PLCO buccal specimens for large-scale studies. The information about the validity of using PLCO buccal cell collection will be an invaluable asset for further large scale studies of the microbiota and cancer risk. We will also be able to investigate if there is any taxonomy or microbial diversity difference between heavy smokers and never-smokers. This pilot study will provide essential information about collection, design and analyses that will enable further studies of the relationships between cigarette smoking, the oral microbiome and tobacco-related cancers.

Under an Amendment, the participants will be contacted to provide another set of oral swabs and mouthwash samples. The goal is to examine the stability or oral microbiota in 3-6 months and confirm the results based on the first time point. The collection methods, assays and analyses will be analogous to those performed previously.

Cigarette Smoking and Oral Microbiota

The Effect of Smoking on Oral Microbiota

This was a descriptive study involving \~ 25 smokers and 25 non-smokers. We found and published in 2017 that alpha diversity was lower in smokers than in nonsmokers in the buccal mucosa, but inother sample sites, microbial diversity and compositionwere not significantly different by smoking status.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)	NCT03750825	Cigarette Smoki...	NIDA Standard R...	22 Years - 55 Years	University of Southern California
Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos	NCT05253573	Cigarette Smoki...	Nicotine patch Self-help mater... Smartphone-base...	18 Years -	University of Oklahoma
The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study	NCT01785537	Cardiovascular ... Chronic Obstruc... Cancer of the L... Cancer of the B... Cancer of the S...		30 Years - 80 Years	Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)	NCT03750825	Cigarette Smoki...	NIDA Standard R...	22 Years - 55 Years	University of Southern California
Cigarette Smoking and Oral Microbiota	NCT01862809	Microbiota Lung Cancer Oral Cancer		25 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)	NCT03750825	Cigarette Smoki...	NIDA Standard R...	22 Years - 55 Years	University of Southern California

Spots Global Cancer Trial Database for cigarette smoking