Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Fralin Biomedical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dual cigarette smokers/e-cigarette users; Dual cigarette smokers/e-cigarette users will be recruited.	Drug: 3 mg/mL nicotine strength e-liquid; Availability of 3 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace; Drug: 6 mg/mL nicotine strength e-liquid; Availability of 6 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace; Drug: 12 mg/mL nicotine strength e-liquid; Availability of 12 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace; Drug: 24 mg/mL nicotine strength e-liquid; Availability of 24 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
Other: Exclusive cigarette smokers; Exclusive cigarette smokers with minimal prior e-cigarette experience will be recruited.	Drug: 3 mg/mL nicotine strength e-liquid; Availability of 3 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace; Drug: 6 mg/mL nicotine strength e-liquid; Availability of 6 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace; Drug: 12 mg/mL nicotine strength e-liquid; Availability of 12 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace; Drug: 24 mg/mL nicotine strength e-liquid; Availability of 24 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Jeff S. Stein, Ph.D., Fralin Biomedical Research Institute at VTC

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 18-268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No