E-Cigarettes' Respiratory Effects in Obese Youth

(RESEC Trial)

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Lung disease, Cardiac event, Metabolic disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how e-cigarettes affect breathing in young people, whether obese or not. Participants will vape using their own devices (referred to as ECIG own) and a study device (referred to as ECIG Vuse) during two sessions to compare the effects. Those who vape daily, do not have lung or heart issues, and can commit to five lab visits might be a good fit. The goal is to understand any differences in respiratory function among different groups of young e-cigarette users.

As an unphased trial, this study allows participants to contribute to important research on the health impacts of e-cigarettes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must abstain from all tobacco and nicotine for at least 12 hours before lab sessions.

What prior data suggests that these vaping products are safe for youth?

Research shows that using e-cigarettes, such as ECIG own, usually doesn't cause serious breathing problems for people who have never smoked. However, users might experience mild coughing or wheezing. Studies also indicate that vaping can lead to nicotine addiction and other health issues, including lung and heart problems.

For ECIG Vuse, young people who vape might notice more breathing issues, such as wheezing and shortness of breath. Some research also links e-cigarette use to a higher risk of respiratory diseases.

Overall, while e-cigarettes are not considered safe and carry risks, the side effects are mostly mild for those who have never smoked. However, awareness of the potential for more serious health concerns is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how e-cigarettes affect the respiratory health of obese youth, a group not typically studied in this context. Unlike traditional options like smoking cessation programs and nicotine replacement therapies, this trial specifically looks at the impact of vaping, using both personal and study-provided e-cigarette devices. This dual-device approach allows researchers to compare the effects of different e-cigarettes, potentially revealing important differences in how they influence lung health. Understanding these effects could lead to more tailored public health strategies for vaping in young, obese populations.

What evidence suggests that this trial's treatments could be effective for respiratory effects in obese youth?

Research shows that e-cigarettes can harm health, particularly the lungs. Some studies have found that people who use both regular cigarettes and e-cigarettes face a higher risk of lung cancer than those who only smoke regular cigarettes. Other research suggests that e-cigarette use links to breathing problems like asthma and can worsen these conditions. Additionally, e-cigarette use has been connected to higher obesity rates, which can further affect breathing. Overall, evidence suggests that e-cigarettes might exacerbate breathing issues rather than improve them. Participants in this trial will undergo two vaping sessions to further investigate these effects. ^{2 5 6 7 8}

Who Is on the Research Team?

Dharini M Bhammar, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for young adults aged 21-25 who use e-cigarettes daily for at least the past three months. Participants must be willing to avoid all tobacco and nicotine for 12 hours before lab visits, attend five sessions up to four hours each, and can read and speak English.

Inclusion Criteria

Current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months

Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions

Willing to complete five lab visits lasting up to 4 hours each

Exclusion Criteria

Currently pregnant, planning to become pregnant, or breastfeeding

Use of other tobacco products >10 days in the past month

Current marijuana use >10 times per month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaping Session 1

Participants vape using their own e-cigarette device while vaping behaviors and respiratory functions are assessed

1 day

1 visit (in-person)

Vaping Session 2

Participants vape using the VUSE e-cigarette device while vaping behaviors and respiratory functions are assessed

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any changes in respiratory function and vaping behaviors

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ECIG own
• ECIG Vuse

Trial Overview The study aims to understand how using different types of e-cigarettes (ECIG own or ECIG Vuse) affects breathing in both obese and non-obese youth. It will involve observing vaping behaviors and measuring respiratory function.

How Is the Trial Designed?

Group I: Vaping Experimental Treatment 2 Interventions

All participants will undergo two vaping sessions: one using their own device and one using the study device

ECIG own is already approved in United States, European Union, Canada for the following indications:

Approved in United States as E-Cigarettes for:

• Nicotine replacement therapy for smoking cessation

Approved in European Union as E-Cigarettes for:

• Nicotine-containing products for smoking cessation

Approved in Canada as E-Cigarettes for:

• Nicotine vaping products for smoking cessation

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a study of 2,086 adolescents, those who used e-cigarettes reported nearly double the risk of chronic bronchitic symptoms compared to non-users, with current users showing even higher risks.

The likelihood of experiencing bronchitic symptoms increased with the frequency of e-cigarette use, highlighting potential long-term respiratory health concerns associated with e-cigarette use among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Cigarette Use and Respiratory Symptoms in Adolescents. McConnell, R., Barrington-Trimis, JL., Wang, K., et al.[2018]

In a study of 2660 Canadian youth aged 16-25, each additional year of vaping exposure significantly increased the risk of respiratory symptoms among never smokers, with a rate ratio of 11.36, indicating a strong association between vaping and respiratory issues.

Current vapers using pod-style devices reported more respiratory symptoms compared to those using other devices, suggesting that certain vaping methods may pose higher risks, especially for non-smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking, e-cigarettes and the effect on respiratory symptoms among a population sample of youth: Retrospective cohort study. Chaiton, M., Pienkowski, M., Musani, I., et al.[2023]

E-cigarettes, initially thought to help adults quit smoking, have become a major gateway for adolescents to start using tobacco, with over 25% of US school-age students now using e-cigs, largely due to targeted marketing strategies.

The use of flavored e-cigarettes has been linked to increased asthma prevalence and exacerbations among adolescents, along with serious health risks like EVALI (vaping-related lung injury), highlighting the urgent need for stricter regulations and protective measures for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protecting youth from the vaping epidemic. Galderisi, A., Ferraro, VA., Caserotti, M., et al.[2021]

A survey of 2693 Canadian pediatricians revealed 88 cases of severe vaping-related injuries and illnesses in children aged 0-17, primarily linked to vaping device use or substance ingestion.

The most common health issues included acute respiratory symptoms and nicotine toxicity, with 15% of cases requiring admission to intensive care, underscoring the urgent need for protective policies against vaping risks for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaping-related injury and illness among Canadian children and adolescents: a one-time survey of paediatric providers. Chadi, N., Moore-Hepburn, C., Beno, S., et al.[2020]

In 2015, e-cigarettes became the most popular tobacco product among U.S. youths, with 5.3% of middle school and 16.0% of high school students reporting use in the past 30 days, highlighting a significant public health concern.

The analysis of the 2015 National Youth Tobacco Survey revealed that a large portion of youth e-cigarette users (32.5%) reported using e-cigarettes for substances other than nicotine, indicating a need for targeted prevention strategies to address diverse e-cigarette use among young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Electronic Cigarette Use Among Middle and High School Students - United States, 2015. Singh, T., Kennedy, S., Marynak, K., et al.[2018]

A review identified 16 programs aimed at preventing and treating e-cigarette use among adolescents, highlighting that most included effective strategies like understanding flavored products and developing refusal skills.

Despite incorporating effective components, many programs lack specific materials on e-cigarettes and require more rigorous evaluations to enhance their effectiveness in reducing adolescent use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Breath of Knowledge: Overview of Current Adolescent E-cigarette Prevention and Cessation Programs. Liu, J., Gaiha, SM., Halpern-Felsher, B.[2022]

Electronic nicotine delivery systems, including vaping devices, are now the most popular tobacco products among youth and young adults, raising concerns about long-term nicotine addiction and the potential for a new generation of smokers.

The rise of vaping has led to serious health issues, including a spike in acute lung injuries known as EVALI, which pose significant risks of morbidity and mortality, highlighting the urgent need for public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-Cigarettes and Other Electronic Nicotine Delivery Systems (ENDS). Brown, A., Balk, SJ.[2021]

The use of e-cigarettes (ENDS) among adolescents has surged, raising concerns about their addictive nature and potential long-term health effects, particularly in young users.

There has been a notable increase in cases of e-cigarette or vaping product use-associated lung injury (EVALI), but most research has focused on adults, highlighting a gap in understanding the impact on pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarette and vaping product use-associated lung injury in the pediatric population: A critical review of the current literature. Kaslow, JA., Rosas-Salazar, C., Moore, PE.[2021]

In a study of 494 adolescents aged 12 to 23, 20% were identified as frequent users of electronic vapor products (EVPs), while 80% were either nonusers or experimenters, highlighting a significant prevalence of EVP use among young people.

Frequent EVP users reported a range of negative symptoms in the past 6 months, including headaches, cough, sleep disturbances, and racing heart, suggesting potential health risks associated with regular vaping and supporting the need for preventive measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors and Medical Symptoms Associated With Electronic Vapor Product Use Among Adolescents and Young Adults. Benyo, SE., Bruinsma, TJ., Drda, E., et al.[2021]

Electronic cigarettes (ECIGs) contain fewer toxic chemicals than conventional cigarettes, but they still pose potential health risks, especially through second-hand exposure to vulnerable populations.

There is insufficient scientific evidence to support the use of ECIGs as an effective smoking cessation aid, and the long-term health effects of ECIG use remain unknown, raising concerns about their safety compared to traditional tobacco products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes: a task force report from the European Respiratory Society. Bals, R., Boyd, J., Esposito, S., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05869318

Respiratory Effects of E-Cigarettes in Obese Youth The investigators hypothesize that obese youth e-cigarette users will have increased e-cigarette use that will worsen respiratory function. The approach will ...

2. withpower.com withpower.com/trial/phase-e-cig-use-3-2023-9824b

E-Cigarettes' Respiratory Effects in Obese Youth (RESEC ... Trial Overview The study aims to understand how using different types of e-cigarettes (ECIG own or ECIG Vuse) affects breathing in both obese and non-obese ...

3. studysearch.osumc.edu studysearch.osumc.edu/sites/default/files/2023-02/41_RESEC%20Protocol2.4.23_CLEAN.pdf

RESEC: RESpiratory effects of E-Cigarettes in obese youth function, respiratory symptoms, and physical activity levels in obese compared with nonobese youth e-cigarette users. Measurements in Specific Aim 1 will be ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35065933/

Predictors of electronic cigarette use and its association ... ... lung function was observed. In addition, the prevalence of overweight/obesity was higher among e-cigarette users compared to non-users (36.7% vs ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9764206/

Health effects and known pathology associated with the use of ... ... obesity was observed [114]. The gestational exposure to e-vapor in combination with a high fat diet led to increased cardiomyocyte (CM) apoptosis and ...

6. nhlbi.nih.gov nhlbi.nih.gov/news/2023/new-study-links-vaping-increased-respiratory-symptoms-young-adults

New study links vaping to increased respiratory symptoms in ... Young people who use electronic cigarettes or vape report increased respiratory symptoms, including wheezing and shortness of breath, compared to those who don ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0013935122000871

Predictors of electronic cigarette use and its association ... E-cigarettes increased the risk of respiratory symptoms if combined with smoking. E-cigarette use was associated with obesity which warrants ...

8. ahajournals.org ahajournals.org/doi/10.1161/RES.0000000000000544

Cardiopulmonary Consequences of Vaping in Adolescents In addition, e-cigarette use was associated with an increased incidence of respiratory disease according to self-reported diagnoses and e- ...