Vaping Device Labeling for Nicotine and Cannabis Use

(EPIC/ADVANCE Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 1

3900 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Vaping Device Labeling for Nicotine and Cannabis Use?

The research suggests that understanding the features of vaping devices, like nicotine content, is important for users, which could imply that clear labeling might help users make informed choices and potentially reduce risks associated with vaping. ^{1 2 3 4 5}

Is vaping device labeling generally safe for human use?

There are safety concerns with vaping devices, such as the potential for nicotine toxicity and inaccurate labeling of nicotine content, which can lead to unexpected exposure levels. Additionally, modifications to these devices by users can change their safety profile. ^{4 5 6 7 8}

How does the treatment of vaping device labeling for nicotine and cannabis use differ from other treatments?

This treatment is unique because it focuses on ensuring accurate labeling of vaping devices, which can help users better understand the nicotine and cannabis content they are consuming. Unlike other treatments that might focus on cessation or harm reduction, this approach aims to improve consumer information and product safety through regulatory compliance and quality control. ^{3 8 9 10 11}

What is the purpose of this trial?

This study assesses how the ways in which nicotine and cannabis vaping devices are labeled impact use susceptibility, anticipated effects, and health harm.

Eligibility Criteria

This trial is for high school students enrolled in partnering schools. It's designed to understand how labeling on nicotine and cannabis vaping devices affects their views and choices regarding vaping.

Inclusion Criteria

Participants must be enrolled in a partnering high school

Exclusion Criteria

Participants who cannot independently understand study consent and the study surveys are ineligible.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Labeling Experiment

Participants view images of vaping devices with different labels and flavors to assess use susceptibility, anticipated effects, and perceived health harms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in perception and intention regarding vaping products

4 weeks

Treatment Details

Interventions

• Vaping Device Labeling

Trial Overview The study is testing the impact of different labels on vaping devices that contain nicotine or cannabis. Researchers want to see if these labels change how likely teens are to use them, what they expect from using them, and their understanding of health risks.

Participant Groups

Group I: Original - Labeling Condition 7 Experimental Treatment 1 Intervention

Participants will view an image of a white colored and original vape with label condition 7.

Group II: Original - Labeling Condition 6 Experimental Treatment 1 Intervention

Participants will view an image of a white colored and original vape with label condition 6.

Group III: Original - Labeling Condition 5 Experimental Treatment 1 Intervention

Participants will view an image of a white colored and original vape with label condition 5.

Group IV: Original - Labeling Condition 4 Experimental Treatment 1 Intervention

Participants will view an image of a white colored and original vape with label condition 4.

Group V: Original - Labeling Condition 3 Experimental Treatment 1 Intervention

Participants will view an image of a white colored and original vape with label condition 3.

Group VI: Original - Labeling Condition 2 Experimental Treatment 1 Intervention

Participants will view an image of a white colored and original vape with label condition 2.

Group VII: Original - Labeling Condition 1 Experimental Treatment 1 Intervention

Participants will view an image of a white colored and original vape with label condition 1.

Group VIII: Mint - Labeling Condition 7 Experimental Treatment 1 Intervention

Participants will view an image of a mint-colored and flavored vape with label condition 7.

Group IX: Mint - Labeling Condition 6 Experimental Treatment 1 Intervention

Participants will view an image of a mint-colored and flavored vape with label condition 6.

Group X: Mint - Labeling Condition 5 Experimental Treatment 1 Intervention

Participants will view an image of a mint-colored and flavored vape with label condition 5.

Group XI: Mint - Labeling Condition 4 Experimental Treatment 1 Intervention

Participants will view an image of a mint-colored and flavored vape with label condition 4.

Group XII: Mint - Labeling Condition 3 Experimental Treatment 1 Intervention

Participants will view an image of a mint-colored and flavored vape with label condition 3.

Group XIII: Mint - Labeling Condition 2 Experimental Treatment 1 Intervention

Participants will view an image of a mint-colored and flavored vape with label condition 2.

Group XIV: Mint - Labeling Condition 1 Experimental Treatment 1 Intervention

Participants will view an image of a mint-colored and flavored vape with label condition 1.

Group XV: Blueberry - Labeling Condition 7 Experimental Treatment 1 Intervention

Participants will view an image of a blue-colored and blueberry flavored vape with label condition 1.

Group XVI: Blueberry - Labeling Condition 6 Experimental Treatment 1 Intervention

Participants will view an image of a blue-colored and blueberry flavored vape with label condition 6.

Group XVII: Blueberry - Labeling Condition 5 Experimental Treatment 1 Intervention

Participants will view an image of a blue-colored and blueberry flavored vape with label condition 5.

Group XVIII: Blueberry - Labeling Condition 4 Experimental Treatment 1 Intervention

Participants will view an image of a blue-colored and blueberry flavored vape with label condition 4.

Group XIX: Blueberry - Labeling Condition 3 Experimental Treatment 1 Intervention

Participants will view an image of a blue-colored and blueberry flavored vape with label condition 3.

Group XX: Blueberry - Labeling Condition 2 Experimental Treatment 1 Intervention

Participants will view an image of a blue-colored and blueberry flavored vape with label condition 2.

Group XXI: Blueberry - Labeling Condition 1 Experimental Treatment 1 Intervention

Participants will view an image of a blue-colored and blueberry flavored vape with label condition 1.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Juul EU delivers significantly less nicotine compared to Juul US and traditional cigarettes, with a maximum nicotine concentration (Cmax) of only 3.8 ng/ml versus 21.1 ng/ml for Juul US, indicating a lower potential for nicotine delivery.

Due to its lower nicotine delivery, Juul EU may have limited effectiveness in helping smokers quit, as users reported it less effective in relieving urges to smoke compared to Juul US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine delivery and user reactions to Juul EU (20 mg/ml) compared with Juul US (59 mg/ml), cigarettes and other e-cigarette products. Phillips-Waller, A., Przulj, D., Smith, KM., et al.[2021]

A study involving in-depth interviews with 13 adult ENDS users revealed that modifications to devices, such as coils and e-liquids, are commonly made to enhance nicotine delivery, flavor, and vapor production.

Despite a reported decline in modifications due to manufacturer changes, hobbyists still engage in extensive modifications, and regulatory actions by the FDA could inadvertently encourage users to revert to more extensive modifications, impacting safety and product toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Users' Modifications to Electronic Nicotine Delivery Systems (ENDS): Interviews with ENDS Enthusiasts. Li, Y., Fairman, RT., Churchill, V., et al.[2020]

A study analyzing calls to U.S. poison centers from September 2010 to February 2014 revealed increasing reports of adverse health effects associated with e-cigarette use, highlighting concerns about acute nicotine toxicity.

E-cigarette exposure calls were compared to conventional tobacco cigarette exposure calls to assess their relative safety, but the overall impact of e-cigarettes on public health remains uncertain, especially given the lack of regulation and potential access for minors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014. Chatham-Stephens, K., Law, R., Taylor, E., et al.[2022]

In a study analyzing 51 e-cigarette products, 23 samples showed significant discrepancies in nicotine concentration, deviating from their labels by more than ±10%, with some variations as extreme as -50.1%.

Out of 39 samples tested for e-liquid volume, 30 also had significant deviations from labeled amounts, highlighting the need for better regulatory oversight to ensure accurate labeling and improve consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Market survey of disposable e-cigarette nicotine content and e-liquid volume. Appleton, S., Cyrus-Miller, H., Seltzer, R., et al.[2022]

References

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

Retrospective review of nicotine exposures in California from 2012 to 2018 and analysis of the impacts of e-cigarette regulations. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Nicotine delivery and user reactions to Juul EU (20 mg/ml) compared with Juul US (59 mg/ml), cigarettes and other e-cigarette products. [2021]

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

Trajectories of Nicotine and Cannabis Vaping and Polyuse From Adolescence to Young Adulthood. [2021]

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

E-cigarettes: What's known, what's unknown. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

"Don't Know" Responses for Nicotine Vaping Product Features among Adult Vapers: Findings from the 2018 and 2020 ITC Four Country Smoking and Vaping Surveys. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Users' Modifications to Electronic Nicotine Delivery Systems (ENDS): Interviews with ENDS Enthusiasts. [2020]

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

Notes from the field: calls to poison centers for exposures to electronic cigarettes--United States, September 2010-February 2014. [2022]

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

Market survey of disposable e-cigarette nicotine content and e-liquid volume. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Nicotine concentrations in electronic cigarette refill and do-it-yourself fluids. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Compliance of e-cigarette refill liquids with regulations on labelling, packaging and technical design characteristics in nine European member states. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Method for Quantifying Variation in the Resistance of Electronic Cigarette Coils. [2022]