E-cigarettes for Tobacco Use

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Under 50, Non-smokers, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether e-cigarettes can help reduce tobacco smoking in adults over 50 who are also receiving treatment for opioid use disorder. Researchers aim to determine if switching to e-cigarettes, without intending to quit smoking, is more acceptable and feasible than traditional brief advice to quit smoking. The trial will also evaluate whether education about nicotine influences participants' understanding. It suits individuals who are 50 or older, currently smoke tobacco regularly, and are undergoing treatment for opioid use disorder. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new insights and options for smoking reduction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on switching from tobacco to e-cigarettes for those in treatment for opioid use disorder.

What prior data suggests that e-cigarettes are safe for older adults who smoke tobacco?

Research has shown that e-cigarettes, such as the NJOY Ace, are generally safe for adults. Studies have found a low risk of death or serious side effects when using e-cigarettes to quit smoking, indicating that most people can use them without major issues.

However, long-term safety can vary. While e-cigarettes might be safer than regular cigarettes, they are not completely risk-free. The FDA has approved NJOY Ace menthol e-cigarettes, confirming they meet certain safety standards, but risks remain, especially for younger individuals.

In summary, e-cigarettes appear to be a safer option than traditional smoking and are usually well-tolerated, but they do carry risks. Participants should consider these points when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of e-cigarettes for tobacco cessation because they offer a new way to help smokers transition away from traditional cigarettes. Unlike conventional methods like nicotine patches or gum, e-cigarettes provide a similar hand-to-mouth experience and can be used on demand, which might make quitting feel more familiar and manageable for smokers. Additionally, e-cigarettes like the NJOY Ace offer customizable options with different flavors, potentially increasing user satisfaction and adherence compared to standard nicotine replacement therapies. This approach could open new avenues for supporting smokers who haven't succeeded with traditional cessation methods.

What evidence suggests that e-cigarettes are an effective harm-reduction tool for older adults who smoke tobacco?

This trial will compare the use of e-cigarettes with standard brief advice for tobacco use. Studies have shown that e-cigarettes can help people reduce or quit smoking regular cigarettes. Research indicates that people who use e-cigarettes are more likely to quit smoking than those who do not. An article from the New England Journal of Medicine found that people using e-cigarettes had a better chance of staying smoke-free for six months. Another study noted that e-cigarettes can help people stop smoking, even if they did not initially plan to quit. These findings suggest that e-cigarettes might be a helpful tool for reducing smoking, especially for those not actively trying to quit. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 50 and older who smoke tobacco and are being treated for opioid use disorder. They should not have any current plans or efforts to quit smoking. The study excludes individuals who do not meet these specific criteria.

Inclusion Criteria

50 years or older; currently in treatment for opioid use disorder for at least 3 months; currently use tobacco (>100 cigarettes in lifetime and smoke every day or some days); expired air CO >8ppm; does not regularly use e-cigarettes (regular use defined as use in the past month for 2 or more consecutive days); not pregnant or breastfeeding

Exclusion Criteria

I am under 50, trying to quit or don't smoke tobacco.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Participants complete a baseline session and are randomly assigned to either receive an e-cigarette product or brief advice to quit smoking

1 day

1 visit (in-person)

Treatment

Participants receive either NJOY Ace e-cigarettes or brief advice for smoking cessation, with follow-up visits at weeks 2, 6, and 8

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in smoking behavior and intention to quit

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• E-cigarette

Trial Overview The study tests if providing e-cigarettes can help older adults switch from smoking tobacco to using e-cigarettes, as a harm-reduction tool. It compares the effectiveness of e-cigarettes with standard advice on quitting smoking over several weeks through follow-up visits.

How Is the Trial Designed?

Group I: Standard brief advice to address tobacco use Experimental Treatment 1 Intervention

Usual Care/Treatment As Usual Patients will be exposed to a brief smoking cessation intervention (BI) based on long-standing tobacco treatment guidelines (Fiore, 2008) and recommendations in the newly revised 4th edition of the ASAM. If a patient reports wanting to stop smoking, they will be instructed to reach out to their medical provider at the treatment clinic. They will be given multiple state and federal resources for quitting smoking. If the patient does not want to quit smoking during the brief intervention, we will check with them during the next session about their interest. The brief smoking intervention will be delivered at each session to check on individuals who are attempting to quit and to possibly motivate those who aren't quitting to initiate a quit attempt.

Group II: E-cigarette switching Active Control 1 Intervention

NJOY Ace e-cigarette (menthol or tobacco flavor, depending on patient preference) to be used ad libitum.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

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]

Nicotine e-cigarettes were found to be more effective for smoking cessation compared to licensed nicotine replacement therapies (NRT), with participants using e-cigarettes being 49% more likely to remain abstinent from smoking than those using NRT.

The review included 7 e-cigarette trials with a total of 5,674 participants and 9 NRT trials with 6,080 participants, but many e-cigarette studies had a moderate to high risk of bias, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. Chan, GCK., Stjepanović, D., Lim, C., et al.[2023]

The E3 trial is a comprehensive study involving 376 participants over 12 weeks, aimed at evaluating the effectiveness of nicotine e-cigarettes compared to non-nicotine e-cigarettes and no e-cigarettes for smoking cessation, with follow-ups extending to 52 weeks.

This trial will provide crucial data on the efficacy and safety of e-cigarettes as a smoking cessation tool, helping inform healthcare professionals and regulators about their potential role in helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design. Hébert-Losier, A., Filion, KB., Windle, SB., et al.[2022]

A study analyzing calls to U.S. poison centers from September 2010 to February 2014 revealed increasing reports of adverse health effects associated with e-cigarette use, highlighting concerns about acute nicotine toxicity.

E-cigarette exposure calls were compared to conventional tobacco cigarette exposure calls to assess their relative safety, but the overall impact of e-cigarettes on public health remains uncertain, especially given the lack of regulation and potential access for minors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014. Chatham-Stephens, K., Law, R., Taylor, E., et al.[2022]

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]

In a study using two validated in vitro models, e-cigarette vapor extracts from three popular brands did not show significant increases in mutations in either mouse or human cells, suggesting limited mutagenic effects.

The research indicates that, at the concentrations tested, e-cig vapor may not pose a significant risk of inducing genetic mutations, which is important for understanding the potential carcinogenic effects of e-cigarette use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited mutagenicity of electronic cigarettes in mouse or human cells in vitro. Tommasi, S., Bates, SE., Behar, RZ., et al.[2018]

Electronic cigarettes are marketed as safe alternatives to traditional tobacco products, but there are growing concerns about their potential negative health impacts.

There is a call for regulatory measures on the manufacturing and marketing of e-cigarettes, as well as further research to better understand their health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes: health risks and workplace policy. Phillips, JA.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4752870/

E-cigarettes and smoking cessation in real-world ... We aimed to assess the association between e-cigarette use and cigarette smoking cessation among adult cigarette smokers, irrespective of their motivation for ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2308815

Electronic Nicotine-Delivery Systems for Smoking Cessation The primary outcome was continuous abstinence from tobacco smoking at 6 months as measured by participant report of no cigarette smoking after ...

3. amjmed.com amjmed.com/article/S0002-9343(23)00295-4/fulltext

Efficacy and Safety of E-Cigarette Use for Smoking Cessation A number of randomized controlled trials (RCTs) have been conducted that examined nicotine and non-nicotine e-cigarettes for smoking cessation, ...

4. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/early/2025/02/20/tc-2024-058798

Vaping cessation interventions: a systematic review and ... E-cigarette users are interested in quitting but have limited success, likely due to the lack of evidence-based interventions to help them quit.

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010216.pub9/full

Electronic cigarettes for smoking cessation - Lindson, N To examine the safety, tolerability, and effectiveness of using EC to help people who smoke tobacco achieve long‐term smoking abstinence, in ...

6. 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 ...

7. fda.gov fda.gov/media/179499/download

TPL Review of PMTAs PD1 is associated with significantly higher smoking cessation rates than tobacco-flavored NJOY ACE products and epidemiology concluded that ...