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

169 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment involving electronic cigarettes and nicotine replacement therapies for smoking reduction?

Research shows that using electronic cigarettes and nicotine replacement therapies (like gum, patches, and lozenges) can help people quit smoking. These treatments can almost double the chances of successfully quitting compared to not using any treatment. ^{1 2 3 4 5}

Is switching to e-cigarettes generally safe for humans?

Research shows that nicotine replacement therapies, including e-cigarettes, have been used for smoking reduction and cessation with an established safety record. However, there are reports of adverse events, so it's important to use them correctly and consult with a healthcare provider. ^{6 7 8 9 10}

How does switching to e-cigarettes for smoking reduction differ from other treatments?

Switching to e-cigarettes for smoking reduction is unique because it mimics the act of smoking more closely than other nicotine replacement therapies (like gum or patches), providing a similar hand-to-mouth action and inhalation experience, which can help satisfy the habitual aspects of smoking. Additionally, e-cigarettes can deliver nicotine more rapidly than some other forms of nicotine replacement, potentially making them more effective for some individuals in reducing cravings. ^{1 3 11 12 13}

What is the purpose of this trial?

This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.

Research Team

Jason Robinson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). [2023]

3. Greece pubmed.ncbi.nlm.nih.gov

Electronic cigarettes versus nicotine-replacement therapy for smoking cessation: A systematic review and meta-analysis of randomized controlled trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of nicotine replacement therapies in smoking cessation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety Profile of Alternative Tobacco and Nicotine Products for Smoking Reduction and Cessation: A Systematic Review. [2023]

8. England 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. [2022]

9. Australia pubmed.ncbi.nlm.nih.gov

Optimising nicotine replacement therapy in clinical practice. [2018]

10. New Zealand 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Smokers who have not tried alternative nicotine products: a 2019 survey of adults in Great Britain. [2021]

12. England pubmed.ncbi.nlm.nih.gov

The future of nicotine replacement. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . [2018]