Switching to E-Cigarettes for Smoking Reduction

Overseen By Jason Robinson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Depression, Uncontrolled conditions, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how switching from traditional cigarettes to electronic cigarettes might affect men and women differently. Researchers are specifically examining the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC), with some participants using nicotine versions and others using a placebo. The trial targets individuals who smoke daily or occasionally and are open to trying tobacco-flavored e-cigarettes. Participants will use these products for six weeks and attend lab visits to help understand potential benefits or differences in quitting smoking. As an unphased trial, this study allows participants to contribute to groundbreaking research on smoking cessation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an uncontrolled or unstable medical condition, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that e-cigarettes might be less harmful than regular cigarettes in the short term. Studies suggest they are about as safe as other products used to help people quit smoking, such as nicotine patches or gum. However, e-cigarettes are not completely risk-free because they often contain nicotine, which is addictive.

While the long-term safety of e-cigarettes is still under investigation, they are considered less harmful than smoking regular cigarettes. Some reports indicate they can help people quit smoking, making them a potential tool for harm reduction. However, e-cigarettes are still relatively new, and more research is needed to fully understand their long-term effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in this trial because they explore switching from traditional smoking to electronic cigarettes (e-cigs) as a way to reduce smoking. Unlike nicotine replacement therapies like patches or gum, e-cigs offer a similar experience to smoking, which might make it easier for smokers to transition away from traditional cigarettes. The study uses a unique approach by testing both nicotine and placebo e-cigs, allowing researchers to understand the role of nicotine itself versus the ritual of smoking. This could provide insights into how e-cigs can be used effectively to reduce smoking habits.

What evidence suggests that this trial's treatments could be effective for smoking reduction?

Research has shown that electronic cigarettes (e-cigs) can help people quit smoking more effectively than some other methods, such as nicotine patches or gum. In this trial, participants will join different treatment arms to test the effectiveness of e-cigs with and without nicotine. Studies indicate that e-cigs with nicotine can lead to higher success rates in quitting. Some research found that using e-cigs for a short time can be more helpful than just receiving advice or counseling. However, not all studies agree, and some suggest that e-cigs might not always help people quit or remain smoke-free. Overall, e-cigs seem to help some people stop smoking, but results can vary. ^{3 6 7 8 9}

Who Is on the Research Team?

Jason Robinson

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult smokers who've been smoking at least 5 cigarettes daily for the past month, have a stable address and phone, can follow instructions in English, and are willing to switch to tobacco-flavored e-cigarettes. Pregnant or breastfeeding women, those not using birth control, people with severe lung obstruction or unstable health conditions like uncontrolled diabetes or hypertension cannot join.

Inclusion Criteria

You are okay with using e-cigarettes that have a tobacco flavor for the study.

You are able to follow verbal and written instructions in English and complete all aspects of the study as determined by the PI.

A stable address and working telephone

Exclusion Criteria

I have been diagnosed with major depression or have had suicidal thoughts.

I have recently started or plan to start a program to quit smoking soon.

My lung function test shows severe to very severe obstruction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Phase I

Participants smoke their usual brand cigarette as they normally would

2 weeks

1 visit (in-person)

Phase II

Participants use only the SREC (with or without nicotine)

2 weeks

1 visit (in-person)

Phase III

Participants continue to use only the SREC (with or without nicotine)

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Cigarette
• Nicotine Replacement

Trial Overview

The study aims to understand gender differences when switching from regular cigarettes to electronic ones provided by the research team. Participants will use these e-cigarettes and complete questionnaires while their lung function is tested twice during the study.

How Is the Trial Designed?

Group I: E-Cig placebo dose followed by E-Cig nicotine dose Experimental Treatment 3 Interventions

Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.

Group II: E-Cig nicotine dose followed by E-Cig placebo dose Experimental Treatment 3 Interventions

Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Nicotinell lozenges, particularly the 1 mg formulation, have been shown to be bioequivalent to 2 mg nicotine gum, providing effective nicotine delivery for smoking cessation, with significant short-term efficacy demonstrated in over 900 smokers.

The lozenges have an excellent safety profile, with only mild and reversible adverse events reported, making them a safe option for smokers seeking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). Dautzenberg, B., Nides, M., Kienzler, JL., et al.[2023]

A systematic review of 44 studies, including 31 randomized controlled trials, found that alternative tobacco and nicotine products like electronic cigarettes (EC), smokeless tobacco, and nicotine replacement therapy (NRT) can moderately reduce daily cigarette consumption and assist in smoking cessation with fewer adverse events.

The evidence supports the potential role of these products in tobacco harm reduction, but further research is needed to evaluate their long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Alternative Tobacco and Nicotine Products for Smoking Reduction and Cessation: A Systematic Review. Zakiyah, N., Purwadi, FV., Insani, WN., et al.[2023]

In a study of 150 participants, e-cigarettes were found to be as effective as nicotine gum for smoking cessation, with no significant differences in overall abstinence rates.

E-cigarettes were associated with a higher proportion of participants showing smoking reduction at 24 weeks and had fewer adverse events compared to nicotine gum, suggesting they may be a safer alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study. Lee, SH., Ahn, SH., Cheong, YS.[2020]

E-cigarettes were found to be more effective than nicotine-replacement therapy (NRT) for achieving continuous smoking abstinence for 6 months or longer, with a relative risk of 1.67 based on a meta-analysis of 5 randomized controlled trials involving 1748 participants.

There were no significant differences in adverse events between e-cigarettes and NRT, except for increased throat irritation associated with e-cigarettes, indicating a similar safety profile overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. Li, J., Hui, X., Fu, J., et al.[2022]

In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.

Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

Nicotine replacement therapy (NRT) has evolved significantly over the past decade, with new delivery methods like mouth sprays, films, and electronic cigarettes showing promise in aiding smoking cessation and harm reduction.

The article reviews the efficacy and tolerability of these novel NRT products, highlighting their advantages and disadvantages compared to traditional NRT forms, which can help inform users about their options for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel delivery systems for nicotine replacement therapy as an aid to smoking cessation and for harm reduction: rationale, and evidence for advantages over existing systems. Shahab, L., Brose, LS., West, R.[2022]

A comprehensive analysis of 8,867,135 reports from the FDA Adverse Event Reporting System revealed that nicotine replacement therapies (NRTs) are associated with several adverse events, including nausea, dizziness, and application site reactions, indicating the need for careful monitoring of their use.

Electronic cigarettes also reported adverse events such as dizziness and increased heart rate, suggesting that while they may be used for smoking cessation, they are not without risks and should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of smoking cessation treatments (nicotine replacement therapy and non-nicotine prescription medication) and electronic cigarettes in the Food and Drug Administration Adverse Event Reporting System, 2004-2016. Motooka, Y., Matsui, T., Slaton, RM., et al.[2022]

The study found that three prototype 4-mg nicotine lozenges produced in India were bioequivalent to the globally marketed Nicorette® 4-mg lozenge, indicating they can effectively deliver similar levels of nicotine to the bloodstream.

All prototype lozenges were well tolerated and had safety profiles comparable to the reference product, suggesting they are a safe alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . Sukhija, M., Srivastava, R., Kaushik, A.[2018]

A meta-analysis of 53 randomized controlled trials involving 17,703 subjects found that nicotine-replacement therapy (NRT) significantly increases the odds of smoking abstinence, with an overall odds ratio of 1.71 compared to control groups.

Different forms of NRT showed varying effectiveness, with inhaled nicotine being the most effective (odds ratio of 3.05), while the effectiveness was largely independent of the level of nicotine dependence and the intensity of additional support provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2019]

Nicotine replacement therapy (NRT) is safe and effective, but it is often used incorrectly; providing clear instructions and adequate dosing is crucial for maximizing its benefits.

Combining different forms of NRT, such as using a nicotine patch with gum or lozenges, and starting the patch two weeks before quitting can significantly improve quit rates and help prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising nicotine replacement therapy in clinical practice. Mendelsohn, C.[2018]

Nicotine replacement therapies (NRTs) significantly increase the chances of quitting smoking, with an overall odds ratio of 1.71 based on a review of 53 trials involving 17,703 patients.

Among different NRT forms, the transdermal patch and inhaled nicotine showed the highest effectiveness, with odds ratios of 2.07 and 3.05 respectively, indicating that these methods may be particularly beneficial for smokers trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of nicotine replacement therapies in smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2019]

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