Health Warning Labels for Vaping

Overseen By Wasim Maziak, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Must not be taking: Prescription medications

Disqualifiers: Chronic disease, Psychiatric conditions, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 2

210 Participants Needed

Trial Summary

What is the purpose of this trial?

In this project, after systematically developing electronic nicotine delivery systems (ENDS) pictorial health warning labels (HWLs), a proven clinical lab model will be used to examine and test their effect when these are placed on the ENDS device on a variety of subjective (e.g. satisfaction, harm perception, nicotine dependence, intention to quit) and objective outcomes (e.g. plasma nicotine, puff topography) in young adults.

Will I have to stop taking my current medications?

The trial excludes individuals who regularly use prescription medications, so you may need to stop taking them to participate. However, vitamins and birth control are allowed.

What data supports the effectiveness of health warning labels on electronic nicotine delivery systems (ENDS) as a treatment?

The research indicates that electronic nicotine delivery systems (ENDS) are used as an aid to quit smoking and for harm reduction, suggesting that health warning labels could potentially enhance their effectiveness by increasing awareness of health risks. ^{1 2 3 4 5}

Is vaping generally safe for humans?

There are concerns about the safety of electronic nicotine delivery systems (ENDS), including e-cigarettes, especially due to incidents of liquid nicotine exposure and potential harm to youth. While they may help some people quit smoking, more research is needed to fully understand their health impacts. ^{1 6 7 8 9}

How do health warning labels for vaping differ from other treatments for vaping-related concerns?

Health warning labels for vaping are unique because they focus on educating users about the risks associated with vaping, rather than providing a direct medical treatment. This approach aims to reduce harm by increasing awareness and potentially influencing behavior, unlike other treatments that might involve medication or therapy to address vaping addiction. ^{1 6 10 11 12}

Research Team

Wasim Maziak, PhD, MD

Principal Investigator

Florida International University

Eligibility Criteria

This trial is for healthy young adults aged 21-35 who use electronic nicotine delivery systems (ENDS) daily or occasionally. Participants must have abstained from ENDS for 12 hours before sessions and be willing to attend lab visits. Excluded are those using other tobacco products, with chronic diseases, cardiovascular issues, high/low blood pressure, seizures, certain medication users, THC users, recent COVID-19 exposure or symptoms.

Inclusion Criteria

Is willing to attend the lab as required by the study protocol

ENDS users (defined as using ENDS either daily or occasionally in the past 30 days)

Generally healthy individuals (determined by physical examination)

Exclusion Criteria

I am not pregnant or breastfeeding.

I have a history of heart issues, blood pressure problems, seizures, or I regularly use prescription medication.

I am currently experiencing symptoms like cough, fever, or chest pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Testing

Systematic development of ENDS pictorial health warning labels and testing their effects on subjective and objective outcomes in a clinical lab model

Varies

Multiple sessions including focus groups and lab visits

Clinical Lab Cross-over Study

Participants use ENDS in two sessions: one with their preferred product without HWL and one with HWL on the device to test effects on satisfaction, dependence, and puffing behavior

2 sessions, each approximately 60 minutes

2 visits (in-person)

Follow-up

Participants are monitored for changes in harm perception, nicotine dependence, and other outcomes after the lab sessions

4 weeks

Treatment Details

Interventions

• Electronic Nicotine Delivery Systems
• Health Warning Labels

Trial Overview The study aims to develop pictorial health warning labels (HWLs) for ENDS devices and test their impact on user perceptions like satisfaction and harm awareness as well as objective measures such as nicotine levels in the blood and puffing patterns during vaping sessions.

Participant Groups

Group I: Preferred ENDS with HWL Experimental Treatment 2 Interventions

All participants will complete a lab visit where they will use their preferred ENDS with a HWL on the device ad libitum for up to 60 minutes

Group II: Preferred ENDS Experimental Treatment 2 Interventions

All participants will complete a lab visit where they will use their preferred ENDS ad libitum for up to 60 minutes

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Findings from Research

E-cigarettes and vaping products, while showing some harm reduction benefits for smoking cessation, still pose significant health risks, particularly among young users who vape THC, as highlighted by the rise in EVALI-related injuries and deaths.

The review emphasizes the need for ongoing monitoring of vaping trends and health impacts, as the popularity of electronic nicotine delivery systems continues to raise concerns despite a decrease in severe incidents since 2019.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

World vaping update. Striley, CW., Nutley, SK.[2021]

In a study involving 108 young adult smokers, exposure to second generation electronic nicotine delivery systems (ENDS) like vape pens triggered smoking urges and desires similar to those caused by traditional combustible cigarettes.

The results indicate that even individuals with no prior experience with ENDS felt increased urges to smoke after being exposed to vape pen cues, suggesting that these devices can act as strong conditioned cues for smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Generation Electronic Nicotine Delivery System Vape Pen Exposure Generalizes as a Smoking Cue. King, AC., Smith, LJ., McNamara, PJ., et al.[2020]

Electronic nicotine delivery systems (ENDS), such as e-cigarettes and vape-pens, have rapidly gained popularity among adolescents, surpassing conventional cigarette use since 2014.

There is a significant concern regarding the health risks of ENDS for adolescents, as they may increase the risk of nicotine addiction and contain harmful chemicals, necessitating healthcare professionals to address this issue in patient counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practitioner's Guide to Electronic Cigarettes in the Adolescent Population. Hildick-Smith, GJ., Pesko, MF., Shearer, L., et al.[2022]

In a study of 395 participants, those who used electronic nicotine delivery systems (ENDS) experienced significant increases in blood pressure, heart rate, and reductions in heart rate variability and airflow after a 15-minute vaping session, indicating acute cardiovascular and pulmonary stress.

Compared to control participants, ENDS users showed similar negative effects to those who smoked traditional cigarettes, including impaired exercise tolerance and increased airflow obstruction, suggesting that ENDS may not be a safer alternative to smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular and Pulmonary Responses to Acute Use of Electronic Nicotine Delivery Systems and Combustible Cigarettes in Long-Term Users. Tattersall, MC., Hughey, CM., Piasecki, TM., et al.[2023]

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]

Graphic warning labels significantly increased the perceived harm of moist snuff and e-cigarettes among 483 adult non-users of tobacco, suggesting that such labels can effectively communicate risks associated with these products.

Conversely, labels suggesting 'lower risk' or 'FDA Approved' decreased the perceived harm of moist snuff and snus, indicating that misleading endorsements can undermine public health efforts and should be regulated against.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsmokers' responses to new warning labels on smokeless tobacco and electronic cigarettes: an experimental study. Popova, L., Ling, PM.[2023]

Between 2012 and 2017, there was a nearly sixfold increase in calls to the British Columbia Poison Centre regarding exposures to electronic nicotine delivery systems (ENDS), primarily due to accidental ingestions in young children, particularly those aged 4 years or less.

Of the 186 unique exposures recorded, 46.8% resulted in reported symptoms, highlighting the need for regulatory measures to reduce children's access to ENDS and improve product safety through better labeling and packaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarette exposures reported to the British Columbia Drug and Poison Information Centre: an observational case series. Choi, A., Le, M., Rahim, T., et al.[2022]

In 2018, an estimated 885 cases of liquid nicotine poisoning among children under 5 were treated in U.S. emergency departments, indicating a concerning trend in exposure.

The majority of these poisoning cases (90%) were treated and released, with ingestion being the most common route of exposure (99.4%), highlighting the need for increased public awareness and safety measures regarding liquid nicotine products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery system (ENDS) liquid nicotine exposure in young children presenting to US emergency departments, 2018. Chang, JT., Rostron, BL.[2022]

Electronic nicotine delivery systems (ENDS), like e-cigarettes, are increasingly popular but their overall health impacts are still unclear, necessitating further research to understand their role in smoking cessation and potential risks, especially for youth.

The American Association for Cancer Research and the American Society of Clinical Oncology recommend strict regulations on ENDS, including ingredient transparency, childproof packaging, and restrictions on marketing to youth, to mitigate potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. Brandon, TH., Goniewicz, ML., Hanna, NH., et al.[2022]

A study involving 1,280 Korean adults found that using a 'dashboard' warning label system significantly increased participants' perception of harm among different tobacco products, indicating it may effectively communicate relative risks.

In contrast, varying the size of warning labels did not influence participants' perceptions of harm or benefits, suggesting that the design of warning labels is crucial for public health messaging about tobacco products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective package warning label systems for communicating relative risks of cigarettes, heated tobacco products, and e-cigarettes: An experimental study with Korean adults. Cho, YJ., Thrasher, JF., Davis, R., et al.[2022]

In a survey of 11,561 respondents across Australia, Canada, England, and the United States, it was found that people in Canada were more likely to notice health warning labels (HWLs) on nicotine vaping products compared to those in England, while those in Australia and the US showed no significant differences.

Despite England having mandatory HWLs, there was no significant increase in concern about using nicotine vaping products among respondents compared to other countries, indicating that the presence of HWLs alone may not effectively raise awareness or concern among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to and perceptions of health warning labels on nicotine vaping products: findings from the 2016 International Tobacco Control Four Country Smoking and Vaping Survey. McDermott, MS., Li, G., McNeill, A., et al.[2020]

Smokers are increasingly using e-cigarettes or electronic nicotine delivery systems (ENDS) as alternatives to traditional combustible tobacco products like cigarettes and cigars.

E-cigarettes are often seen as a tool for smoking cessation, providing a different method for nicotine delivery compared to conventional smoking methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of E-Cigarettes and Vaping. [2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

World vaping update. [2021]

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

Second Generation Electronic Nicotine Delivery System Vape Pen Exposure Generalizes as a Smoking Cue. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A Practitioner's Guide to Electronic Cigarettes in the Adolescent Population. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular and Pulmonary Responses to Acute Use of Electronic Nicotine Delivery Systems and Combustible Cigarettes in Long-Term Users. [2023]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Nonsmokers' responses to new warning labels on smokeless tobacco and electronic cigarettes: an experimental study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Electronic cigarette exposures reported to the British Columbia Drug and Poison Information Centre: an observational case series. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery system (ENDS) liquid nicotine exposure in young children presenting to US emergency departments, 2018. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effective package warning label systems for communicating relative risks of cigarettes, heated tobacco products, and e-cigarettes: An experimental study with Korean adults. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Exposure to and perceptions of health warning labels on nicotine vaping products: findings from the 2016 International Tobacco Control Four Country Smoking and Vaping Survey. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Use of E-Cigarettes and Vaping. [2020]