E-Cigarettes for Smoking

Overseen By Nancy A. Rigotti, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Plans to quit, Recent cessation treatment, Recent EC use, Recent hospitalization, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks). The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.

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, it focuses on switching from regular cigarettes to electronic cigarettes for 4 weeks.

What data supports the effectiveness of the treatment NJOY ACE e-cigarette for smoking cessation?

Research shows that electronic cigarettes, like the NJOY ACE, can help people reduce or quit smoking by delivering nicotine in a way that mimics traditional cigarettes, which may make it easier for smokers to transition away from smoking. ^{1 2 3 4 5}

How is the NJOY ACE e-cigarette treatment different from other smoking cessation treatments?

The NJOY ACE e-cigarette is unique because it delivers nicotine without the harmful constituents of tobacco smoke, unlike traditional smoking cessation methods that may involve nicotine replacement therapies like patches or gum. However, its long-term health effects are still unknown, and it may expose users to harmful chemicals found in e-liquids. ^{6 7 8 9 10}

Research Team

Nancy Rigotti, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals who have not quit smoking after cessation treatment during lung cancer screening and don't plan to quit. They must be willing to switch from regular cigarettes to an e-cigarette (NJOY ACE) for 4 weeks.

Inclusion Criteria

I completed the Screen Assist study and showed interest in switching from regular to electronic cigarettes.

Smoked ≥5 cigarettes/day in past month

Smoking status at study entry confirmed by breath carbon monoxide (CO) ≥ 6ppm

Exclusion Criteria

Not willing to abstain from smoking marijuana in the 24h before each study visit

I plan to quit smoking within the next 30 days.

Used smoking cessation treatment in the past 30 days

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive NJOY ACE 5% nicotine electronic cigarettes for 4 weeks as a substitute for smoking combustible cigarettes

4 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for tobacco use behavior and biomarker changes after the end of e-cigarette provision

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• NJOY ACE e-cigarette

Trial Overview The study tests the feasibility of using e-cigarettes as a tobacco harm reduction strategy by providing participants with NJOY ACE e-cigarettes. It measures changes in smoking behavior and health indicators over an 8-week period.

Participant Groups

Group I: NJOY ACE e-cigarette provision Experimental Treatment 1 Intervention

Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

University of Massachusetts, Boston

Collaborator

Trials

42

Recruited

17,800+

Findings from Research

E-cigarettes have been shown to significantly reduce the desire to smoke and the number of cigarettes smoked per day in small clinical studies, suggesting they may help modify smoking habits.

While e-cigarettes may have fewer adverse effects compared to nicotine patches and can aid in short-term smoking reduction, there is limited evidence for their long-term effectiveness in achieving sustained smoking cessation beyond 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of electronic cigarettes for smoking cessation. Orr, KK., Asal, NJ.[2018]

In a study involving 24 adult smokers, the JUUL System (JS) with higher nicotine concentrations (59 mg/mL) resulted in significantly greater plasma nicotine levels and craving relief compared to lower concentrations (18 and 9 mg/mL) and usual brand cigarettes.

The findings suggest that heavier smokers may need higher nicotine delivery systems, like the JS 59 mg/mL, to effectively transition away from traditional cigarettes, as lower concentrations did not provide the same level of satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-Label, Randomized, Controlled, Crossover Study to Assess Nicotine Pharmacokinetics and Subjective Effects of the JUUL System with Three Nicotine Concentrations Relative to Combustible Cigarettes in Adult Smokers. Goldenson, NI., Fearon, IM., Buchhalter, AR., et al.[2021]

The NJOY® King Bold Electronic Nicotine Delivery System (ENDS) effectively delivers nicotine, with blood levels increasing by an average of 3.5 ng/mL within 5 minutes of use, significantly reducing cravings by 55%.

During a one-week study with 25 adult smokers, participants reduced their cigarette consumption by 39%, indicating the potential of this ENDS for short-term smoking reduction or cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine blood levels and short-term smoking reduction with an electronic nicotine delivery system. Nides, MA., Leischow, SJ., Bhatter, M., et al.[2022]

E-cigarettes showed a 33% improvement in the 1-month continuous abstinence rate compared to other methods, based on a review of 12 trials with 9863 participants, indicating potential short-term efficacy for smoking cessation.

However, there is very low certainty regarding the long-term safety and efficacy of e-cigarettes for quitting smoking, as evidence for sustained abstinence beyond 12 months is insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Electronic Cigarettes for Smoking Cessation: A Systematic Review and Meta-Analysis. Ibrahim, S., Habiballah, M., Sayed, IE.[2021]

Electronic nicotine delivery systems (ENDS), particularly JUUL, are being evaluated for their potential as smoking cessation tools, but their appeal to non-smokers raises public health concerns.

There is a need for clear definitions and well-controlled studies to understand the role of ENDS in harm reduction, as current metrics complicate conclusions about their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closing Perspective on the Special Issue on JUUL. Fagerström, KO.[2021]

A survey of 2,103 young people aged 11-18 in Great Britain revealed that many have inaccurate perceptions about the harm of e-cigarettes and nicotine, with older teens (16+) showing a higher understanding of e-cigarette risks.

Accurate perceptions of e-cigarette harm were linked to factors such as family e-cigarette use and public attitudes towards smoking, indicating that social influences play a significant role in shaping these beliefs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harm perceptions of electronic cigarettes and nicotine: A nationally representative cross-sectional survey of young people in Great Britain. East, K., Brose, LS., McNeill, A., et al.[2023]

A nationwide survey of 13,162 Malaysian adolescents found that 9% had used e-cigarettes in the past month, with higher usage among males, older teens (16-19 years), and those who smoke cigarettes.

The main reasons for starting e-cigarette use included appealing flavors, curiosity, and popularity, highlighting the need for stricter regulations, such as banning sales to those under 18 and flavored e-cigarettes to reduce youth appeal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With E-Cigarette Usage and the Reasons for Initiation Among Malaysian Adolescents. Robert Lourdes, TG., Abd Hamid, HA., Mohd Yusoff, MF., et al.[2020]

A 17-year-old male developed severe respiratory issues, including acute bronchiolitis and chronic airflow obstruction, after intensive vaping of flavored e-liquids, suggesting a potential link to bronchiolitis obliterans, also known as 'popcorn lung'.

Despite treatment with high-dose corticosteroids and mechanical ventilation, the patient experienced lasting pulmonary function impairment, highlighting the serious and possibly long-term health risks associated with vaping, which necessitates further research and regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth. Landman, ST., Dhaliwal, I., Mackenzie, CA., et al.[2023]

Only 12.7% of healthcare professionals in Slovenia recommend electronic cigarettes for smoking cessation, but 33.1% would suggest them for specific patient groups, indicating a cautious approach to their use.

Knowledge about electronic cigarettes significantly influences healthcare professionals' recommendations, highlighting the need for better training and guidelines to support effective counseling on their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beliefs and practices regarding electronic cigarettes in smoking cessation among healthcare professionals in Slovenia. Koprivnikar, H., Zupanič, T., Farkas, JL.[2020]

The Dutch government's proposal to restrict e-liquids to only tobacco flavors aims to reduce e-cigarette use among youth, as sweet and fruity flavors are particularly appealing to both young non-smokers and adult smokers.

A final list of 16 tobacco flavorings was created by excluding over 480 flavors based on their prevalence, health effects, and association with sweetness, which may discourage youth use but could also limit the appeal of e-cigarettes as a smoking cessation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing attractiveness of e-liquids: proposal for a restrictive list of tobacco-related flavourings. Pennings, JLA., Havermans, A., Krüsemann, EJZ., et al.[2023]

References

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

Efficacy of electronic cigarettes for smoking cessation. [2018]

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

An Open-Label, Randomized, Controlled, Crossover Study to Assess Nicotine Pharmacokinetics and Subjective Effects of the JUUL System with Three Nicotine Concentrations Relative to Combustible Cigarettes in Adult Smokers. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Nicotine blood levels and short-term smoking reduction with an electronic nicotine delivery system. [2022]

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

Efficacy of Electronic Cigarettes for Smoking Cessation: A Systematic Review and Meta-Analysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Closing Perspective on the Special Issue on JUUL. [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

Harm perceptions of electronic cigarettes and nicotine: A nationally representative cross-sectional survey of young people in Great Britain. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Factors Associated With E-Cigarette Usage and the Reasons for Initiation Among Malaysian Adolescents. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Life-threatening bronchiolitis related to electronic cigarette use in a Canadian youth. [2023]

9. Greece pubmed.ncbi.nlm.nih.gov

Beliefs and practices regarding electronic cigarettes in smoking cessation among healthcare professionals in Slovenia. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Reducing attractiveness of e-liquids: proposal for a restrictive list of tobacco-related flavourings. [2023]