What side effects are associated with this type of intervention?

Common treatments for smoking cessation include nicotine replacement therapies (NRTs) such as patches, gums, and lozenges, as well as prescription medications like varenicline and bupropion. Switching from cigarette smoking to e-cigarette use is also being studied as a potential cessation method. Known side effects of these treatments can include nausea, mouth irritation, hiccups, difficulty sleeping, and vivid dreams. E-cigarette use may also carry risks related to respiratory symptoms and potential carcinogenic effects, although these are generally considered lower than those associated with traditional cigarette smoking.

What prior FDA approvals exist?

The FDA has approved several treatments for smoking cessation, including nicotine replacement therapies (NRTs) such as nicotine patches, gums, and lozenges, as well as prescription medications like bupropion (Zyban) and varenicline (Chantix). These treatments aim to reduce withdrawal symptoms and cravings, thereby aiding in smoking cessation. While e-cigarettes are not FDA-approved as smoking cessation devices, they are being studied for their potential to reduce harm by lowering exposure to harmful chemicals found in traditional cigarettes. The ongoing study on switching from cigarette smoking to e-cigarette use focuses on evaluating the impact on cancer-related biomarkers in the oral epithelium, which is a novel approach compared to traditional pharmacotherapies.

What other types of research exist?

Promising, novel alternatives to switching from cigarette smoking to e-cigarette use for patients considering treatment in 2024 include: 1) Pharmacotherapy options such as varenicline, bupropion, and nicotine replacement therapy (NRT) which have shown effectiveness in smoking cessation without the potential carcinogenic risks associated with e-cigarettes. 2) Digital interventions like mobile phone-based apps and web-based programs that provide real-time support and monitoring. 3) Behavioral therapies including acceptance and commitment therapy (ACT) and mindfulness-based interventions which address the psychological aspects of addiction. 4) Group behavior therapy programs which offer peer support and structured guidance. These alternatives focus on reducing smoking-related harm and improving cessation rates without introducing new potential risks.

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Vaping for Smokers' Cancer Risk

N/A

Waitlist Available

Led By Ahmad Besaratinia

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Being male or female between the ages of 22-55

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)

Must not have

Having used any medication known to induce/inhibit CYP450 2A6 enzyme

Having any unstable or significant medical condition (e.g., symptomatic heart conditions) in the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 weeks for 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if switching from regular cigarettes to e-cigarettes affects cancer risk. It involves smokers who switch to e-cigs, smokers who continue smoking, and non-smokers. Researchers will collect cheek cells and look for changes that could indicate cancer risk.

Who is the study for?

This trial is for smokers aged 22-55 who've smoked more than 5 cigarettes daily for over a year and want to switch to vaping, continue smoking, or remain smoke/vape-free. Participants must be able to consent and follow the study without major life disruptions. Those with severe mental illness, substance abuse, extreme body weight, recent pregnancy or drug use, certain medical conditions or treatments are excluded.

What is being tested?

The study compares cancer-related biomarkers in oral cells among three groups: smokers switching to e-cigarettes (Grp 1), regular smokers (Grp 2), and non-smokers/non-vapers (Grp 3). It uses 'multi-omics' analysis on genome changes relevant to cancer risk during the intervention.

What are the potential side effects?

Potential side effects may include irritation from e-cigarette ingredients like propylene glycol/vegetable glycerin in those switching from smoking to vaping. Regular health risks associated with continued smoking will persist for Grp 2.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 55 years old.

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I have smoked more than 5 cigarettes daily for at least a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken medication that affects the CYP450 2A6 enzyme.

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I haven't had any serious or unstable health issues like heart problems in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 weeks for 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2 weeks for 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 weeks for 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Epigenetic changes

Genetic changes

Secondary study objectives

DNA methylation

Gene expression

Histone modifications

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: VapersExperimental Treatment1 Intervention

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

Group II: SmokersActive Control1 Intervention

Smokers will continue to smoke.

Group III: Nonsmokers non-vapersActive Control1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for smoking cessation include pharmacological options like nicotine replacement therapy (NRT), varenicline, and bupropion, which work by reducing withdrawal symptoms and cravings through different mechanisms. NRT provides nicotine without harmful tobacco smoke, while varenicline and bupropion target nicotine receptors in the brain. Behavioral approaches, such as counseling and mindfulness, support patients in changing their smoking behaviors and developing coping strategies. These treatments are crucial as they help reduce the health risks associated with smoking, including cancer. The study on switching from cigarette smoking to e-cigarette use aims to determine if e-cigarettes, which deliver nicotine without many of the carcinogens in tobacco smoke, can lower cancer-related biomarkers in the oral epithelium, potentially offering a less harmful alternative.

SMOKING CESSATION TREATMENTS: CURRENT PSYCHOLOGICAL AND PHARMACOLOGICAL OPTIONS.Tailoring nicotine replacement therapy: rationale and potential approaches.Pharmacotherapy for treating tobacco dependence: what is the ideal duration of therapy?