CClinicalTrials.gg
CompletedNCT03843047Updated Nov 22, 2022

Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace

An interventional study of 3 mg/mL nicotine strength e-liquid and 6 mg/mL nicotine strength e-liquid in Tobacco Use, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-22.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Electronic cigarettes (e-cigarettes) may be a safer alternative to conventional cigarettes and are available in a broad range of nicotine strengths. The overall goal of this project is to use an experimental analogue of the real-world tobacco marketplace to examine the effects of nicotine strength on e-cigarette consumption and the likelihood that current smokers will either switch to e-cigarettes (which may reduce harm) or use both products in combination (which may increase harm). Testing effects of e-cigarette nicotine strength under controlled conditions in a context that models the real world will facilitate evidence-based policies that have a net benefit to health.

Read the detailed description

The goal of tobacco regulation is to reduce tobacco-related harm and improve public health. Improving public health in this way requires thorough understanding of the processes underlying purchasing and consumption of the various products available in the complex tobacco marketplace. One product feature eligible for regulation is the nicotine content in electronic cigarettes (e-cigarettes). At present, little research has experimentally examined the influence of nicotine strength on e-cigarette consumption and the likelihood that current cigarette smokers will switch to e-cigarettes (i.e., product substitution). In the absence of such evidence, regulation designed to restrict available e-cigarette nicotine strength may have unanticipated consequences. This project will utilize an innovative method, the Experimental Tobacco Marketplace, to provide estimates of the effects of e-cigarette nicotine strength on tobacco consumption and the degree to which e-cigarette products serve as functional substitutes for cigarettes. In so doing, this project will provide rigorous tests of a novel quantitative model able to account for e-cigarette substitution effects, including effects of nicotine strength. This model, which assumes that product substitution is directly influenced by the nicotine content of tobacco products relative to their prices (a phenomenon called unit price), provides a framework that may be used to generate novel predictions and guide regulatory efforts. This project will examine the effects of four e-cigarette nicotine strengths (3, 6, 12, and 24 mg/mL) on the degree to which e-liquid substitutes for conventional cigarettes in the Experimental Tobacco Marketplace. This project will examine these effects in: a) exclusive cigarette smokers with minimal prior e-cigarette experience, and b) dual cigarette smokers/e-cigarette users. Together, the findings from this project may be used to inform regulatory action and will improve understanding of the role of nicotine strength in determining the extent to which e-cigarettes serve as functional substitutes for conventional cigarettes.

02

Conditions studied

  • Tobacco Use
03

In context

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Current cigarette smoker
  • Current e-cigarette user (dual users arm) or have minimal prior e-cigarette experience (exclusive smokers arm)
  • Cotinine levels that confirm tobacco use
  • Willing to try e-cigarettes

Exclusion criteria

Exclusion Criteria:

  • Unstable psychiatric or medical conditions
  • Immediate plans to quit smoking
  • Use of prescription medication that might affect smoking or nicotine metabolism
  • Pregnancy (females)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Other
    Dual cigarette smokers/e-cigarette users

    Dual cigarette smokers/e-cigarette users will be recruited.

    Drug: 3 mg/mL nicotine strength e-liquid · Drug: 6 mg/mL nicotine strength e-liquid · Drug: 12 mg/mL nicotine strength e-liquid · Drug: 24 mg/mL nicotine strength e-liquid

  • Other
    Exclusive cigarette smokers

    Exclusive cigarette smokers with minimal prior e-cigarette experience will be recruited.

    Drug: 3 mg/mL nicotine strength e-liquid · Drug: 6 mg/mL nicotine strength e-liquid · Drug: 12 mg/mL nicotine strength e-liquid · Drug: 24 mg/mL nicotine strength e-liquid

Interventions

  • Drug3 mg/mL nicotine strength e-liquid

    Availability of 3 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace

  • Drug6 mg/mL nicotine strength e-liquid

    Availability of 6 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace

  • Drug12 mg/mL nicotine strength e-liquid

    Availability of 12 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace

  • Drug24 mg/mL nicotine strength e-liquid

    Availability of 24 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace

06

What researchers measure

Primary outcomes

  1. E-liquid substitution

    The degree to which various e-liquid nicotine strengths (3, 6, 12, 24 mg/mL) substitute for conventional cigarettes will be assessed.

    Time frame: 1 day

Secondary outcomes

  1. Cigarette demand

    The degree to which various e-liquid nicotine strengths (3, 6, 12, 24 mg/mL) influence demand form conventional cigarettes will be assessed.

    Time frame: 1 day

07

Study locations

1 site
  • Fralin Biomedical Research Institute
    Roanoke, Virginia 24016, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03843047
Lead sponsor
Virginia Polytechnic Institute and State University
Responsible party
Jeffrey Stein (Research Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Feb 15, 2019
Start date
Mar 1, 2019
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Nov 22, 2022

Study contacts

Jeff S. Stein, Ph.D.
principal investigator · Fralin Biomedical Research Institute at VTC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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