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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using e-cigarettes (ECs) for four weeks can help individuals who have not quit smoking after trying other treatments. Participants will switch from regular cigarettes to NJOY ACE e-cigarettes to determine if they smoke fewer regular cigarettes. The trial also evaluates the ease and acceptability of using e-cigarettes as a substitute. Suitable candidates have smoked at least 5 cigarettes daily in the past month, are willing to try switching to e-cigarettes, and can visit Massachusetts General Hospital for check-ins. As an unphased trial, this study provides a unique opportunity to explore new methods for quitting smoking.

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 prior data suggests that the NJOY ACE e-cigarette is safe for use?

Research has shown that the FDA has approved the NJOY ACE e-cigarette for sale, indicating it has met certain safety standards compared to other tobacco products. However, no tobacco product is completely without risk. The specific risks of NJOY products remain not fully known. Therefore, even with FDA approval, users should exercise caution. Remember, using any tobacco product carries risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods like nicotine patches, gums, or prescription medications, the NJOY ACE e-cigarette offers a novel approach to smoking cessation by providing a familiar smoking experience with 5% nicotine in a tobacco flavor. This e-cigarette allows users to mimic the hand-to-mouth action and inhalation similar to combustible cigarettes, potentially making the transition away from smoking easier for users. Researchers are excited about this treatment because it could provide a more satisfying and effective alternative for smokers who struggle with quitting through conventional methods.

What evidence suggests that the NJOY ACE e-cigarette is effective for reducing cigarette use?

Research has shown that electronic cigarettes, such as the NJOY ACE, can help people reduce or quit smoking. In this trial, participants will use the NJOY ACE e-cigarette for 4 weeks as a substitute for combustible cigarettes. These devices deliver nicotine similarly to traditional smoking but without burning tobacco. Studies suggest they can decrease the number of cigarettes smoked daily. By switching to e-cigarettes, smokers might inhale fewer harmful substances, like carbon monoxide, found in regular cigarettes. Although e-cigarettes carry risks, they may offer a safer option for those attempting to quit smoking entirely. ^{5 6 7 8 9}

Who Is on the Research Team?

Nancy Rigotti, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

Smoked ≥5 cigarettes/day in past month

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

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

Exclusion Criteria

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

Used smoking cessation treatment in the past 30 days

I plan to quit smoking within the next 30 days.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1.

fda.gov

fda.gov/media/179499/download

TPL Review of PMTAs

In addition to. NJOY ACE products' robust absolute switching rates ranging from. %, these data provide robust and reliable evidence that the ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9112866/

Quitting Electronic Cigarettes: Factors Associated with Quitting ...

This study aimed to identify factors associated with e-cigarette quitting interest and quitting behaviors in exclusive, long-term e-cigarette users.

3.

withpower.com

withpower.com/trial/phase-nicotine-dependence-8-2024-41c44

E-Cigarettes for Smoking · Info for Participants

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 ...

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/78/NCT05525078/Prot_SAP_002.pdf

Protocol version February 7, 2023 1

The research protocol calls for smokers assigned to the Meds group to use nicotine replacement therapy, and those assigned to the Switch group to use NJOY ACE e ...

5.

qeios.com

qeios.com/read/PHO20L.2

FDA Decision to Authorize NJOY ACE Menthol Was Based ...

Given that e-cigarettes are not without risk, a concluding statement could clarify that, although NJOY ACE may reduce harm compared to ...

6.

njoy.com

njoy.com/gtc/additional-information

Additional Information - NJOY.com - Official Website for NJOY

⚠ WARNING: No tobacco product is safe or without risk. The risks and effects of using NJOY® products have not been established. NJOY® products can expose you to ...

7.

fda.gov

fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-decisions-njoy-ace-e-cigarette-products

FDA Issues Marketing Decisions on NJOY Ace E-Cigarette ...

On April 26, the FDA issued decisions on multiple NJOY Ace e-cigarette products, including the authorization of four new tobacco products.

8.

qeios.com

qeios.com/read/PHO20L

FDA Decision to Authorize NJOY ACE Menthol Was Based ...

Evidence from NYTS clearly proves that these products pose the greatest risk to youth use. The 2023 NYTS data show that among youth who ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11752517/

Physical and Chemical Characterization of Aerosols ...

Similarly, the NJOY Daily ERT 6% which contained low quantities of benzoic acid in the e-liquid did not produce detectable amounts of benzoic acid in the ...