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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how labels on nicotine and cannabis vaping devices affect people's interest in using them, their expectations, and their views on health risks. Different groups will encounter various flavors and colors of vapes, such as mint or blueberry, and researchers will study their reactions to these label conditions. Ideal participants are high school students capable of understanding and completing the study surveys independently. As an unphased study, this trial provides a unique opportunity to contribute to understanding how labeling influences vaping choices and perceptions.

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 prior data suggests that vaping device labeling is safe?

Research shows that vaping devices, whether for nicotine or cannabis, present safety concerns. Nicotine is highly addictive, and the nicotine content in these devices is sometimes mislabeled. This discrepancy can lead to unexpected exposure.

For cannabis vaping, studies have also shown that labels can be inaccurate. Some products might contain less of the claimed compounds, such as CBD, a compound in cannabis. Contamination poses another risk, as harmful substances might be present.

While no evidence suggests that labeling in this trial is unsafe, awareness of these general vaping safety issues remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different labeling on vaping devices might influence nicotine and cannabis use. Unlike traditional approaches that focus solely on the chemical composition of vapes or smoking cessation aids, this trial targets consumer perception and behavior through visual and flavor cues. By examining various label conditions across flavors like mint, blueberry, and original, the trial aims to uncover insights into how packaging and presentation can impact user choices and potentially guide better regulatory practices. This could lead to more effective public health strategies tailored to reduce vaping among different demographic groups.

What evidence suggests that vaping device labeling is effective for influencing use susceptibility and health perceptions?

Research shows that labels on vaping devices can influence perceptions, particularly for nicotine and cannabis. This trial will explore various labeling conditions, such as flavors like mint or blueberry, to assess their impact on participants' perceptions and choices. Studies have found that different labels can affect the likelihood of trying vaping and beliefs about its health effects. Labels highlighting flavors or risks can increase curiosity or caution. This study aims to understand how these label differences affect opinions and choices. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06919276

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9232951/

Dual Use of Nicotine and Cannabis Through Vaping ... This study seeks to identify adolescent nicotine and cannabis vaping patterns and the characteristics of those adolescents who comprised each pattern.

3. withpower.com withpower.com/trial/phase-cannabis-2-2025-dc2cb

Vaping Device Labeling for Nicotine and Cannabis Use · ... This study assesses how the ways in which nicotine and cannabis vaping devices are labeled impact use susceptibility, anticipated effects, and health harm. Show ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S177322472501161X

Aerosolized THC for medical use: assessing the potential ... This study evaluates the in vitro performance of two vaping technologies for the delivery of THC aerosols intended for medical use: a CE-marked medical device ( ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545160/

Electronic Vaping Delivery of Cannabis and Nicotine - NCBI [16] A systematic review found evidence that e-cigarettes can cause addiction in nonsmokers and that young nonsmokers who use e-cigarettes are more likely than ...

6. cannaspecialists.org cannaspecialists.org/the_safety_concerns_of_cannabinoid_vaping_products

The Safety Concerns of Cannabinoid Vaping Products Contamination and mislabeling: Independent lab tests show many cannabinoid vapes are inaccurately labeled. Some contain less CBD than advertised ...

7. ajpmonline.org ajpmonline.org/article/S0749-3797(25)00147-3/fulltext

Adolescent Cannabis Vaping Trends (2021–2023): Delta-9 ... This study reveals that vaping of delta-9-tetrahydrocannabinol, cannabidiol, and synthetic cannabinoids has increased among US adolescents from 2021 to 2023.