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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking. Participants will not have a plan to quit smoking and will not be actively trying to quit smoking at the start of the trial. The main questions the study aims to answer are: * Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don\'t have a plan to quit? * Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation (control)? * Does the accuracy of nicotine/tobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education? Participants will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8, each lasting 30-90 minutes, for a total of approximately 3-4 hours of participation in the study. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning. Patients will be randomly assigned at baseline (if meeting eligibility criteria) to receive an e-cigarette product (name of product: NJOY Ace) or brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine).

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 data supports the effectiveness of the treatment E-cigarette for tobacco use?

Research shows that e-cigarettes can help people quit smoking by providing nicotine and mimicking the act of smoking, which can reduce withdrawal symptoms. Studies have found that e-cigarettes may be more effective than nicotine patches in helping smokers quit. ^{1 2 3 4 5}

What safety data exists for e-cigarettes in humans?

E-cigarettes can cause acute nicotine toxicity, and there are concerns about their potential to cause sudden or long-term health effects due to exposure to complex chemicals. While they are marketed as safer alternatives to tobacco, the presence of toxicants and carcinogens in e-cigarette liquid and vapor raises safety concerns. ^{6 7 8 9 10}

How do e-cigarettes differ from other treatments for tobacco use?

E-cigarettes are unique because they deliver nicotine without the harmful constituents of tobacco smoke, potentially helping smokers quit traditional cigarettes. Unlike other treatments, they simulate smoking by vaporizing nicotine-containing solutions, which may appeal to those who miss the physical act of smoking. ^{11 12 13 14 15}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

References

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

A systematic review of randomized controlled trials and network meta-analysis of e-cigarettes for smoking cessation. [2023]

3. United States 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. [2022]

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Electronic cigarettes for smoking cessation: a randomised controlled trial. [2023]

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Limited mutagenicity of electronic cigarettes in mouse or human cells in vitro. [2018]

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

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

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