What is the mechanism of action of this treatment?

The most common treatments for tobacco smoking include nicotine replacement therapies (NRTs) and electronic nicotine delivery systems (ENDS). NRTs, such as patches, gums, and lozenges, work by delivering a controlled amount of nicotine to the body to reduce withdrawal symptoms and cravings, making it easier for individuals to quit smoking. ENDS, like e-cigarettes, deliver nicotine through vaporization, mimicking the act of smoking without the harmful combustion products found in traditional cigarettes. These treatments are crucial for tobacco smoking patients as they provide a safer alternative to smoking, help manage withdrawal symptoms, and increase the likelihood of successful smoking cessation.

What side effects are associated with this type of intervention?

Electronic Nicotine Delivery Systems (ENDS), such as e-cigarettes, can cause side effects including throat and mouth irritation, cough, nausea, and dizziness. Long-term health effects are still uncertain, but there are concerns about potential respiratory and cardiovascular issues. Other common nicotine replacement therapies (NRTs) like patches, gums, and lozenges may cause skin irritation, hiccups, and gastrointestinal discomfort. It's important to discuss these options with a healthcare provider to determine the most suitable and safe method for smoking cessation.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for smoking cessation, including nicotine replacement therapies (NRTs) such as nicotine patches, gum, lozenges, nasal sprays, and inhalers. These products deliver nicotine in controlled doses to help reduce withdrawal symptoms and cravings. Additionally, the FDA has approved non-nicotine medications like varenicline (Chantix) and bupropion (Zyban) that aid in smoking cessation by targeting nicotine receptors in the brain. While there is ongoing research and some evidence suggesting that electronic nicotine delivery systems (ENDS) may help with smoking reduction and cessation, there is currently insufficient evidence to definitively support their use for this purpose, and they are not yet FDA-approved as smoking cessation aids.

What other types of research exist?

Promising alternatives to Cartridge-based ENDS for tobacco smoking patients include: 1) Nicotine Replacement Therapy (NRT) such as patches, gums, and lozenges, which provide controlled doses of nicotine to reduce withdrawal symptoms. 2) Prescription medications like varenicline and bupropion, which help reduce cravings and withdrawal symptoms. 3) Behavioral interventions including counseling and support groups, which address the psychological aspects of addiction. 4) Emerging technologies such as heated tobacco products, which heat tobacco without combustion, potentially reducing exposure to harmful chemicals. 5) Digital health tools and mobile apps designed to support smoking cessation through personalized plans and real-time support.

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E-Cigarettes for Tobacco Smoking

N/A

Waitlist Available

Research Sponsored by RAI Services Company

Eligibility Criteria Checklist

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

Must have

Generally healthy adult males or females, 21-60 years old, verified with government-issued photo ID

Must be a current smoker of manufactured menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and smoked on at least 20 days out of the past 30 days

Must not have

Female subjects who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report

Female subjects who state they are not using adequate methods to prevent pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests different e-cigarettes with various flavors and nicotine levels on regular smokers. It aims to see if these smokers will switch to e-cigarettes when given multiple options. Participants will use these e-cigarettes in their daily lives and report their usage.

Who is the study for?

This study is for U.S. adult smokers aged 21-60 who smoke more than 5 cigarettes daily and have done so on most days in the past month. Participants must not be planning to quit soon, be in good physical and mental health, and not use other nicotine delivery systems regularly.

What is being tested?

The trial tests various flavors of a cartridge-based electronic nicotine delivery system (ENDS) over six weeks. Smokers are randomly assigned to tobacco, menthol, or non-tobacco-non-menthol flavors and report their usage along with any cigarette smoking through an eDiary.

What are the potential side effects?

While specific side effects aren't listed here, ENDS can potentially cause throat irritation, coughing, dry mouth or throat, dizziness due to nicotine intake variations from traditional cigarettes.

Eligibility Criteria

Inclusion Criteria

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

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I am a healthy adult between 21 and 60 years old.

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I currently smoke regularly and have smoked at least 100 cigarettes in my life.

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I agree to participate in the study for 8 weeks, follow all requirements, and not share the study treatments.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, nor planning to in the next 6 months.

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I am not using birth control.

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I am not pregnant, as confirmed by a test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

CPD mean percent reduction

Number and proportion of subjects who reduce their cigarettes per day (CPD).

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Active Control

Group I: Tobacco FlavorActive Control4 Interventions

Can choose between 2 different tobacco flavor variants at 2 different nicotine levels (1.5% and 5%)

Group II: Menthol FlavorActive Control4 Interventions

Can choose between 2 different menthol flavor variants at 2 different nicotine levels (1.5% and 5%)

Group III: NTNM FlavorActive Control4 Interventions

Can choose between 2 different non tobacco/non menthol flavor variants at 2 different nicotine levels (1.5% and 5%)

0 / 6Eligibility 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

The most common treatments for tobacco smoking include nicotine replacement therapies (NRTs) and electronic nicotine delivery systems (ENDS). NRTs, such as patches, gums, and lozenges, work by delivering a controlled amount of nicotine to the body to reduce withdrawal symptoms and cravings, making it easier for individuals to quit smoking. ENDS, like e-cigarettes, deliver nicotine through vaporization, mimicking the act of smoking without the harmful combustion products found in traditional cigarettes. These treatments are crucial for tobacco smoking patients as they provide a safer alternative to smoking, help manage withdrawal symptoms, and increase the likelihood of successful smoking cessation.

Effect of Electronic Nicotine Delivery Systems on Cigarette Abstinence in Smokers With No Plans to Quit: Exploratory Analysis of a Randomized Placebo-Controlled Trial.Assessing Electronic Nicotine Delivery Systems Use at NCI-Designated Cancer Centers in the Cancer Moonshot-funded Cancer Center Cessation Initiative.Smoking cessation in individuals who use vaping as compared with traditional nicotine replacement therapies: a systematic review and meta-analysis.