Tobacco product administration and assessment for Electronic Nicotine Delivery System Flavors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Virginia Commonwealth University, Richmond, VA
Electronic Nicotine Delivery System Flavors
Tobacco product administration and assessment - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Electronic Nicotine Delivery System Flavors

Study Objectives

This trial is evaluating whether Tobacco product administration and assessment will improve 3 primary outcomes and 4 secondary outcomes in patients with Electronic Nicotine Delivery System Flavors. Measurement will happen over the course of Week 6.

Week 6
Change in Average Daily Cigarette Use
Change in Average Daily ENDS Use
Change in Carbon Monoxide Exposure
Change in NNAL Exposure
Change in Proplyne Glycol Exposure
Week 6
Willingness to Pay for ENDS
Willingness to Substitute from Cigarettes to ENDS

Trial Safety

Safety Progress

1 of 3

Other trials for Electronic Nicotine Delivery System Flavors

Trial Design

3 Treatment Groups

Menthol+Tobacco
1 of 3
Unflavored
1 of 3
Tobacco
1 of 3
Active Control
Experimental Treatment

This trial requires 210 total participants across 3 different treatment groups

This trial involves 3 different treatments. Tobacco Product Administration And Assessment is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Unflavored
Other
Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems
Tobacco
Other
Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems
Menthol+Tobacco
Other
Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 1 vs. week 6
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 1 vs. week 6 for reporting.

Closest Location

Virginia Commonwealth University - Richmond, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must be 21 years of age to purchase alcohol. show original
I identify as Black/African American. show original
Smokers who have used ≥5 cigarettes per day for ≥1 year are at high risk for lung cancer. show original
I don't really remember the last time I used an ENDS device show original
I do not plan on quitting smoking within the next 6 months. show original
In the past, you may have tried quitting smoking using a method that is based on evidence. show original
We are willing to receive phone calls/text messages and complete internet-based/online surveys related to the study. show original
have a working mobile phone with a texting/data plan
The text states that the smoking status of a person has been confirmed by means of biochemical analysis. show original
Some regular cigarette brands are flavored to taste like menthol or mint. show original

Patient Q&A Section

What causes electronic nicotine delivery system flavors?

"Recent findings indicate that E-NDS flavor preference was primarily due to the flavors' pleasurability rather than their perceived health-promoting properties. Flavor intensity was not a factor; however, E-NDS flavor intensity was associated with higher preference, in the strongest case, reflecting an inherent reward system response common to many electronic devices." - Anonymous Online Contributor

Unverified Answer

What are the signs of electronic nicotine delivery system flavors?

"A unique feature of e-cigarettes is the lack of standardized regulatory requirements governing their flavors, with flavors similar to traditional cigarettes common. These flavors are used primarily by novice users to initiate their vaping habit, and include fruit flavors most commonly used to introduce children to e-cigarette use. As a result, children or adolescents can unknowingly initiate the use of these products. It is unclear whether these flavors have the potential to cause cancer, and clinical trials are needed to establish causal relationships." - Anonymous Online Contributor

Unverified Answer

How many people get electronic nicotine delivery system flavors a year in the United States?

"Despite popular use of e-cigarette products in the US, there is not much recent evidence to suggest the prevalence of electronic cigarettes is increasing or they are becoming a mainstream tobacco product among U.S. smokers. Results from a recent paper provide some recent data in this regard." - Anonymous Online Contributor

Unverified Answer

Can electronic nicotine delivery system flavors be cured?

"These data suggest that the development of an electronic cigarette flavor design that improves the tolerability of the flavor may enhance flavors' ability to effectively deliver nicotine." - Anonymous Online Contributor

Unverified Answer

What is electronic nicotine delivery system flavors?

"E-cigarettes containing sweet flavors, particularly sucrose, may be particularly appealing to youth and will be less effective in reducing smoking rates than flavors that taste like conventional cigarettes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for electronic nicotine delivery system flavors?

"E-cigarettes will remain an important source for nicotine (and potentially other constituents) for some time and so are likely to be part of the'smoking'substance of choice' to some degree. E-cigarette manufacturers and regulators need to anticipate consumer confusion between their products and traditional cigarettes, and anticipate nicotine exposure for those using tobacco substitutes." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating electronic nicotine delivery system flavors?

"Data from a recent study have shown that the addition of new flavors on e-liquor, such as mango or banana, had no effects. There have been no further findings on improving the flavor properties of e-liquid flavors, and flavors that had been introduced to the market prior to the present study remain the best options for consumers for these products." - Anonymous Online Contributor

Unverified Answer

Has tobacco product administration and assessment proven to be more effective than a placebo?

"In a recent study, findings of this trial show that in individuals with a recent cigarette use history, smoking a flavored-strip tobacco product is a more effective method of reducing cigarette cue reactivity than is a placebo tobacco product. The data can help policy makers and health care providers make informed decisions about the effectiveness of various tobacco-cessation treatments." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tobacco product administration and assessment for therapeutic use?

"The introduction of e-cigarettes introduces products with novel product characteristics (i.e. flavors and nicotine delivery system) that may be acceptable to young individuals, as well as to clinicians. They might also be used by tobacco users in addition to cigarette smoking as part of a cessation strategy. Given e-liquids are currently used in clinical and scientific research, clinical evaluation of e-cigarettes might occur more effectively and quickly than with traditional cigarettes, and in a manner similar to other therapeutics/medical products." - Anonymous Online Contributor

Unverified Answer

How does tobacco product administration and assessment work?

"E-cigarettes or e-cigarette liquids contain nicotine and may cause an acute rise in plasma nicotine levels. Plasma nicotine levels are higher from cigarette administration or inhalation of liquids. The acute effects of nicotine in e-cigarettes with or without liquids differ from conventional cigarettes. The acute effects from use of all tested products were similar; i.e. these products were not substantially different in their ability to produce plasma nicotine or to produce acute nicotine-related responses following administration of nicotine. The products tested were not suitable for comparative effectiveness research to conventional cigarettes." - Anonymous Online Contributor

Unverified Answer

What is the latest research for electronic nicotine delivery system flavors?

"The latest research for E-cigarettes flavor formulations highlights the importance of cigarette-specific research for flavors to inform the development of acceptable flavors and nicotine replacement therapy in general." - Anonymous Online Contributor

Unverified Answer

How serious can electronic nicotine delivery system flavors be?

"The effects of electronic NDS flavors, particularly concerning nicotine dependence, are most likely moderate effects. It is likely that many consumers will continue to choose electronic NDS flavors. While several electronic NDS flavors could increase the number of cigarette smokers by attracting existing smokers or inducing never-smokers to begin, the potential negative health effects caused by electronic nicotine delivery systems may outweigh any potential benefits." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Electronic Nicotine Delivery System Flavors by sharing your contact details with the study coordinator.