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Completed

NCT Number: NCT03843047

Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

3 mg/mL nicotine strength e-liquid

Drug

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

6 mg/mL nicotine strength e-liquid

Drug

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

12 mg/mL nicotine strength e-liquid

Drug

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

24 mg/mL nicotine strength e-liquid

Drug

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

Primary outcomes

  1. E-liquid substitution

    Time frame: 1 day

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

Secondary outcomes

  1. Cigarette demand

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

Effects of Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace on Tobacco Product Substitution

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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