Electronic Cigarette Unit Price Manipulations in the Experimental Tobacco Marketplace

NCT03843047 | Completed

• 1 other identifier: 18-268
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use

Outcome Measures

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.

  1 day

Secondary Outcomes (1)

• Cigarette demand

  1 day

Study Arms (2)

Dual cigarette smokers/e-cigarette users

OTHER

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

Exclusive cigarette smokers

OTHER

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

3 mg/mL nicotine strength e-liquid DRUG

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

Dual cigarette smokers/e-cigarette users; Exclusive cigarette smokers

6 mg/mL nicotine strength e-liquid DRUG

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

Dual cigarette smokers/e-cigarette users; Exclusive cigarette smokers

12 mg/mL nicotine strength e-liquid DRUG

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

Dual cigarette smokers/e-cigarette users; Exclusive cigarette smokers

24 mg/mL nicotine strength e-liquid DRUG

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

Dual cigarette smokers/e-cigarette users; Exclusive cigarette smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jeff S. Stein, Ph.D.

  Fralin Biomedical Research Institute at VTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Participants will complete different purchasing scenarios in the Experimental Tobacco Marketplace in which different e-liquid nicotine concentrations are available (3, 6, 12, and 24 mg/mL nicotine). In all scenarios, a range of other tobacco products will also be available.

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

US (1)