E-cigarettes for COPD

Overseen By Timothy Sheehan

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Antiarrhythmics, Seizure medications

Disqualifiers: Drug abuse, Pregnancy, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes (EC) on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that the smokers who switch to EC completely or significantly will experience reduced COPD symptoms, risks of exacerbations, and decreased levels of oxidative stress and inflammation.

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 are on antiarrhythmic drugs or medications to prevent seizures, you may not be eligible to participate.

What data supports the effectiveness of the treatment JUUL e-cigarette for COPD?

Research suggests that electronic nicotine delivery systems (ENDS), like JUUL, may help reduce smoking or assist in quitting smoking, which could indirectly benefit people with COPD by reducing exposure to harmful cigarette smoke. ^{1 2 3 4 5}

How does the treatment using JUUL and NJOY e-cigarettes differ from other treatments for COPD?

The use of JUUL and NJOY e-cigarettes as a treatment for COPD is unique because they are electronic nicotine delivery systems (ENDS) that provide nicotine without the harmful smoke of traditional cigarettes, potentially aiding in smoking reduction or cessation. Unlike standard COPD treatments, which typically focus on managing symptoms and improving lung function, these e-cigarettes may help reduce smoking-related harm by offering a less harmful alternative to smoking. ^{1 3 4 6 7}

Research Team

Rebecca Bascom, MD

Principal Investigator

Penn State Health Hershey Medical Center

Raghu Sinha, PhD

Principal Investigator

Penn State Health Hershey Medical Center

Eligibility Criteria

This trial is for smokers with mild to moderate COPD who currently smoke a popular brand of cigarette and are willing to switch to using an e-cigarette. Participants must be able to give informed consent, attend study visits, read and write English, and agree to reduce their smoking by at least 25%. People with uncontrolled high blood pressure, drug or alcohol abuse history, allergies to e-cigarette ingredients, seizure disorders, recent heart issues or those pregnant/nursing cannot join.

Inclusion Criteria

I have mild to moderate chronic obstructive pulmonary disease.

I have mild to moderate COPD.

Ability to provide informed consent and attend study visits

Exclusion Criteria

My blood pressure is not controlled by medication.

I have a history of seizures or take medication to prevent them.

I have used tobacco products other than cigarettes in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch from cigarettes to NJOY e-cigarettes and are monitored for changes in COPD symptoms and biomarkers

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• JUUL e-cigarette
• NJOY e-cigarette

Trial Overview The study tests if switching from regular cigarettes to NJOY e-cigarettes reduces symptoms of COPD and lowers the risk of exacerbations. It also looks at whether this switch decreases oxidative stress and inflammation in smokers with preexisting COPD.

Participant Groups

Group I: NJOY e-cigarette Experimental Treatment 1 Intervention

NJOY e-cigarette containing 5% nicotine strength pods

JUUL e-cigarette is already approved in United States, European Union, Canada for the following indications:

Approved in United States as JUUL e-cigarette for:

• Nicotine replacement therapy for smoking cessation

Approved in European Union as JUUL e-cigarette for:

• Nicotine replacement therapy for smoking cessation

Approved in Canada as JUUL e-cigarette for:

• Nicotine replacement therapy for smoking cessation

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

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]

The entry of the JUUL electronic nicotine delivery system (ENDS) into the Canadian market was associated with a significant average decrease of 1.65% in cigarette sales per month, particularly in urban areas, indicating that JUUL may serve as a substitute for combustible cigarettes.

The study utilized a unique dataset from a major Canadian retailer and employed robust statistical methods to confirm that the availability of ENDS products like JUUL can effectively reduce local cigarette consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of JUUL market entry on cigarette sales: evidence from a major chain retailer in Canada. Xu, Y., Sen, A., Chen, T., et al.[2023]

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 study of five brands of electronic nicotine delivery systems (ENDS) revealed significant design flaws, including leaking cartridges and difficulty in handling without exposure to nicotine, raising safety concerns for users.

The labeling and instructions for ENDS were often inadequate and misleading, lacking essential safety information and proper disposal guidelines, suggesting a need for regulatory review before these products remain on the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: is there a need for regulation? Trtchounian, A., Talbot, P.[2022]

In a study of 6,794 cigarette-only users, the cessation rates for electronic nicotine delivery systems (ENDS), nicotine replacement therapy (NRT), and non-NRT medications were found to be similar, with no significant differences in effectiveness (around 16% for ENDS and NRT, and 17.7% for non-NRT).

A concerning finding was that 37.6% of those who used ENDS to quit smoking became dual users of ENDS and cigarettes, highlighting the potential risk of continued nicotine dependence and the need for smokers to rely on FDA-approved cessation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of ENDS, NRT and medication for smoking cessation among cigarette-only users: a longitudinal analysis of PATH Study wave 3 (2015-2016) and 4 (2016-2017), adult data. Kaplan, B., Galiatsatos, P., Breland, A., et al.[2023]

In a study of 4909 adults who were established users of electronic nicotine delivery systems (ENDS), 9.8% reported having chronic obstructive pulmonary disease (COPD), with the highest prevalence (19.9%) among users of tobacco-flavored ENDS.

Tobacco-flavored ENDS were found to have a significantly higher association with self-reported COPD (adjusted odds ratio of 2.05) compared to non-tobacco flavors, suggesting a potential link between tobacco flavor use and respiratory health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of flavored electronic nicotine delivery system (ENDS) use with self-reported chronic obstructive pulmonary disease (COPD): Results from the Population Assessment of Tobacco and Health (PATH) study, Wave 4. Shi, H., Tavárez, ZQ., Xie, Z., et al.[2021]

Electronic nicotine delivery systems (ENDS) have evolved to become more sophisticated and efficient, potentially aiding in smoking cessation, but they also pose risks due to the inhalation of various compounds over time.

There is a need for more high-quality research to better understand the health effects and safety of ENDS, as well as their effectiveness in helping people quit smoking, especially given their increasing use for illicit drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems (ENDS): A convenient means of smoking? Sala, M., Gotti, C.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

The impact of JUUL market entry on cigarette sales: evidence from a major chain retailer in Canada. [2023]

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

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

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

Electronic nicotine delivery systems: is there a need for regulation? [2022]

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

Effectiveness of ENDS, NRT and medication for smoking cessation among cigarette-only users: a longitudinal analysis of PATH Study wave 3 (2015-2016) and 4 (2016-2017), adult data. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Association of flavored electronic nicotine delivery system (ENDS) use with self-reported chronic obstructive pulmonary disease (COPD): Results from the Population Assessment of Tobacco and Health (PATH) study, Wave 4. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems (ENDS): A convenient means of smoking? [2023]