E-cigarettes for COPD

Recruiting in Palo Alto (17 mi)

Overseen by Rebecca Bascom, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Antiarrhythmics, Seizure medications

Disqualifiers: Drug abuse, Pregnancy, Heart failure, others

No Placebo Group

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.

Trial 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 (Vaporizer)
• NJOY e-cigarette (Vaporizer)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Penn State Health Milton S. Hershey Medical Center Hershey, PA

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Patients Recruited

2,873,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+

References

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

Nicotine blood levels and short-term smoking reduction with an electronic nicotine delivery system. [2022] To evaluate nicotine delivery from the NJOY® King Bold Electronic Nicotine Delivery System (ENDS) and its short-term potential for smoking reduction or cessation.

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] Electronic nicotine delivery systems (ENDS), such as the JUUL system, are nicotine products for adults who currently smoke cigarettes but are looking for an alternative to combustible cigarettes. Sales of ENDS products were legislatively acknowledged and authorized federally in Canada with the Royal Assent of the Tobacco and Vaping Products Act in 2018.

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

Closing Perspective on the Special Issue on JUUL. [2021] Objective: This article provides an overview of this theme issue of the American Journal of Health Behavior dedicated to electronic nicotine delivery systems (ENDS), with a special focus on JUUL. Methods: The author summarizes key findings from included papers and offers an evaluative perspective on ENDS as tools for smoking cessation versus the prospect of their appeal to previous non-smokers. Results: Delineation of certain metrics (eg, defining who is a smoker) and clarification about an acceptable level of unintended consequences weighed against harm reduction confound conclusions about the public health role of ENDS/JUUL. Conclusion: Until agreement on key definitions and performance of well-controlled studies, a system that promotes ENDS/JUUL use among smokers but discourages their use by never-smokers is a regulatory challenge.

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

Electronic nicotine delivery systems: is there a need for regulation? [2022] Electronic nicotine delivery systems (ENDS) purport to deliver nicotine to the lungs of smokers. Five brands of ENDS were evaluated for design features, accuracy and clarity of labelling and quality of instruction manuals and associated print material supplied with products or on manufacturers' websites.

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] Research is inconclusive on the effectiveness of electronic nicotine delivery systems (ENDS) as cigarette cessation aids compared with nicotine replacement therapy (NRT) or non-NRT medication. This study compared the cigarette cessation rates for ENDS, NRT and non-NRT medication.

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] Flavors other than tobacco flavor have been identified as a major reason for electronic nicotine delivery system (ENDS) initiation in youth and are thought to contribute to the continued use of ENDS in users of all ages. Our previous research showed a significant association between overall ENDS use and COPD. This study aims to identify the association of ENDS flavor categories with self-reported COPD.

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

Electronic nicotine delivery systems (ENDS): A convenient means of smoking? [2023] Electronic nicotine delivery systems (ENDS), which are becoming increasingly popular in many parts of the world, have recently become more sophisticated in terms of their more active content and better controlled vaporisation. This review begins by describing how cigarette smoking led to the development of ENDS as a means of combatting nicotine addiction. ENDS are usually categorised as belonging to one of only three main generations, but a fourth has been added in order to differentiate the latest, most powerful, most advanced and innovative that have improved heating efficiency. Descriptions of the principal substances contained in ENDS are followed by considerations concerning the risk of toxicity due to the presence of albeit low concentrations of such a variety of compounds inhaled over a long time, and the increasingly widespread use of ENDS as a means of smoking illicit drugs. We also review the most widely used pharmacotherapeutic approaches to smoking cessation, and recent epidemiological data showing that ENDS can help some people to stop smoking. However, in order to ensure their appropriate regulation, there is a need for higher-quality evidence concerning the health effects and safety of ENDS, and their effectiveness in discouraging tobacco smoking.