E-Cigarettes' Respiratory Effects in Obese Youth
(RESEC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University Comprehensive Cancer Center
Disqualifiers: Lung disease, Cardiac event, Metabolic disease, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.
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.
Are e-cigarettes safe for use in obese youth?
E-cigarettes can cause lung injuries and other health issues, especially in young people. They contain potentially harmful chemicals, and their long-term safety is not well understood. Some users have reported symptoms like headaches, cough, and chest pain.
12345How does the treatment of e-cigarettes differ from other treatments for respiratory effects in obese youth?
E-cigarettes, unlike traditional treatments, are primarily used for smoking cessation or recreational purposes, but they can introduce harmful chemicals and irritants into the lungs, potentially worsening respiratory symptoms in youth. This treatment is unique because it involves inhaling aerosols that contain toxic substances, which can lead to respiratory issues and nicotine addiction, especially in adolescents.
678910Eligibility Criteria
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
Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
Current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months
I am between 21 and 25 years old.
+3 more
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
+7 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: VapingExperimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State UniversityColumbus, OH
Loading ...
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
References
E-cigarette and vaping product use-associated lung injury in the pediatric population: A critical review of the current literature. [2021]Use of electronic nicotine delivery systems (ENDS), also known as e-cigarettes, in the adolescent population has significantly increased over the past several years. This rise led to an outbreak of e-cigarette or vaping product use-associated lung injury (EVALI) in the summer of 2019. Since that time, numerous case reports and case series on vaping and EVALI have been published but the majority of literature highlights the adult population with few articles focusing on pediatric patients. Given the addictive nature of these products and the lack of full understanding of the human health effects, there is concern that use of ENDS may have lasting impacts on users, especially adolescents and young adults. The goal of this review is to critically assess published data on ENDS use in children, report our institutional experience, discuss the reasons why the use of ENDS have increased among young individuals, outline the current understanding of EVALI as it pertains to the pediatric population, and discuss future opportunities for health policy implementation.
Vaping-related injury and illness among Canadian children and adolescents: a one-time survey of paediatric providers. [2020]A one-time survey distributed to 2693 Canadian paediatricians enrolled in the Canadian Paediatric Surveillance Programme was conducted between October and December 2019. We identified a wide range of severe vaping-related injuries and illnesses among children ages 0-17 (n=88), which were associated with the routine use or malfunctioning of a vaping device or the ingestion of vaping substances. The most common clinical presentations were acute respiratory symptoms and nicotine toxicity and 15% (n=13) of injuries required intensive care unit admission. Our study highlights the urgent need for substantive policy measures to help protect youth against the risks associated with vaping products.
Characteristics of Electronic Cigarette Use Among Middle and High School Students - United States, 2015. [2018]Electronic cigarettes (e-cigarettes) are now the most commonly used tobacco product among U.S. youths (1,2); in 2015, 5.3% of middle school students and 16.0% of high school students reported using e-cigarettes in the past 30 days (1). However, limited information exists on the e-cigarette product types and brands used and the substances used in these products by youths. CDC and the Food and Drug Administration (FDA) analyzed data from the 2015 National Youth Tobacco Survey (NYTS) to examine the characteristics of e-cigarette use among U.S. middle (grades 6-8) and high (grades 9-12) school students in 2015, including types of products used, brands of products used, and whether substances other than nicotine were used with the products. Among respondents reporting ever having used an e-cigarette, 14.5% used only disposable e-cigarettes, 53.4% used only rechargeable/refillable e-cigarettes, and 32.1% used both types. Two of the most commonly used e-cigarette brands were blu (26.4%, 1.65 million youths) and VUSE (12.2%, 760,000 youths); half of students (50.7%, 3.18 million) did not know the brand of e-cigarette they used. One third (32.5%) of those who reported ever using an e-cigarette also reported having used e-cigarettes for substances other than nicotine. Preventing youths from beginning use of any tobacco product, including e-cigarettes, is critical to tobacco use prevention and control strategies in the United States (3). Monitoring the characteristics of e-cigarette use among youths, including product types, brands, and ingredients, is important to inform strategies to prevent and reduce e-cigarette use among youths.
Electronic cigarettes: a task force report from the European Respiratory Society. [2020]There is a marked increase in the development and use of electronic nicotine delivery systems or electronic cigarettes (ECIGs). This statement covers electronic cigarettes (ECIGs), defined as "electrical devices that generate an aerosol from a liquid" and thus excludes devices that contain tobacco. Database searches identified published articles that were used to summarise the current knowledge on the epidemiology of ECIG use; their ingredients and accompanied health effects; second-hand exposure; use of ECIGs for smoking cessation; behavioural aspects of ECIGs and social impact; in vitro and animal studies; and user perspectives.ECIG aerosol contains potentially toxic chemicals. As compared to conventional cigarettes, these are fewer and generally in lower concentrations. Second-hand exposures to ECIG chemicals may represent a potential risk, especially to vulnerable populations. There is not enough scientific evidence to support ECIGs as an aid to smoking cessation due to a lack of controlled trials, including those that compare ECIGs with licenced stop-smoking treatments. So far, there are conflicting data that use of ECIGs results in a renormalisation of smoking behaviour or for the gateway hypothesis. Experiments in cell cultures and animal studies show that ECIGs can have multiple negative effects. The long-term effects of ECIG use are unknown, and there is therefore no evidence that ECIGs are safer than tobacco in the long term. Based on current knowledge, negative health effects cannot be ruled out.
Risk Factors and Medical Symptoms Associated With Electronic Vapor Product Use Among Adolescents and Young Adults. [2021]The use of electronic vapor products (EVPs) has increased dramatically in the past decade. The objectives of our study were to examine the frequency of EVP use; to identify demographic characteristics, risk-taking behaviors, and beliefs about vaping; and to determine symptoms associated with EVPs among adolescents. A questionnaire addressing these objectives was administered to a convenience sample of subjects aged 12 to 23 years. Among 494 completed questionnaires, 80% of responders were considered experimenters/nonusers (never tried or tried one time) and 20% were considered frequent users (at least once a month). We identified demographic features and risk-taking behaviors associated with EVP use. In the previous 6 months, frequent users were more likely to report headache, cough, sleep disturbances, dehydration, weakness, racing heart, chest pain, and tremors. Our findings provide evidence to support efforts to decrease EVP use through screening, education, and preventative strategies.
Electronic Cigarette Use and Respiratory Symptoms in Adolescents. [2018]Rates of adolescent electronic (e-) cigarette use are increasing, but there has been little study of the chronic effects of use. Components of e-cigarette aerosol have known pulmonary toxicity.
Smoking, e-cigarettes and the effect on respiratory symptoms among a population sample of youth: Retrospective cohort study. [2023]E-cigarettes have been steadily increasing in popularity, both as cessation methods for smoking and for recreational and social reasons. This increase in vaping may pose cardiovascular and respiratory risks. We aimed to assess respiratory symptoms in youth users of e-cigarettes and cigarettes.
A Breath of Knowledge: Overview of Current Adolescent E-cigarette Prevention and Cessation Programs. [2022]Adolescent use of electronic cigarettes (e-cigarettes) has risen rapidly, which is concerning given the health effects of e-cigarettes and youth susceptibility to nicotine addiction. It is critical that efforts to educate, prevent, and reduce adolescent use of e-cigarettes are developed and evaluated. The purpose of this paper is to review available current prevention and cessation programs.
E-Cigarettes and Other Electronic Nicotine Delivery Systems (ENDS). [2021]Electronic nicotine delivery systems and vaping devices are now the most commonly used forms of tobacco consumed by youth and young adults. A variety of chemicals and toxicants released during inhalation have harmful systemic effects and effects on the lung. The known and potential health consequences are particularly alarming. There is concern that use of these devices will create a new generation of life-long smokers with nicotine and polysubstance addiction. Beyond the concerning chronic health effects of regular use, there is a recent epidemic of severe, acute lung disease termed e-cigarette, or vaping product use-associated lung injury, (EVALI), associated with high morbidity and mortality. These issues demand immediate public health attention. Healthcare providers play key roles in limiting the exposure of youth and young adults to these products by providing evidence-based counseling to patients and families, and by advocating for regulations to protect against childhood initiation and continuation of use.
Protecting youth from the vaping epidemic. [2021]E-cigarettes (e-cigs) have been initially proposed as an aid to smoke cessation in adults, whereas they turned into a paradoxical preferential gateway to tobacco and nicotine initiation for adolescents naïve to tobacco. More than 25% of US school-age students is an e-cigs user with a steep rise over the past years. A marketing strategy on media and social network targeting youths, in the absence of rules to protect the pediatric users, resulted in an unprecedented trend up in tobacco consumption among adolescents and gave rise to a new generation of nicotine-addicted teenagers. Flavored e-cigs liquids and aerosols contain airway irritants and toxicants, that, in turn, produced an increase in asthma prevalence and its exacerbations among adolescents. In addition, since August 2019 an outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) has been described. In view of this, e-cigs must no longer be considered harmless, especially in adolescents never used a tobacco product before. This is a call-for-action to establish effective rules and campaigns targeting youths aimed to limit their access to e-cigs, thereby preserving the potential benefit in quitting tobacco addiction described in adults. Behavioral and educational actions, out of the conventional primary care setting, have been described as a model for a youth-centered campaign. We call for stricter regulations on e-cigs products, with respect to their marketing to the youngest ones, along with public health and primary care interventions that could curb the spread of this "vaping" epidemic.