Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type

Sponsor
Virginia Polytechnic Institute and State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05177848
Collaborator
Medical University of South Carolina (Other), National Cancer Institute (NCI) (NIH)
52
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20.1
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Study Details

Study Description

Brief Summary

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.

Condition or Disease Intervention/Treatment Phase
  • Other: All nicotine/ tobacco products at market price
  • Other: Nicotine vaping products at 1/2 market price
  • Other: Nicotine vaping products at 2x market price
  • Other: Heated tobacco products at 1/2 market price.
  • Other: Heated tobacco products at 2x market price.
  • Other: Nicotine pouch products at 1/2 market price.
  • Other: Nicotine pouch products at 2x market price.
N/A

Detailed Description

An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products [NVP], heated tobacco products [HTP], and nicotine pouch products [NPP]), and how the appeal is modulated by relative price and user type. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type
Actual Study Start Date :
Jun 29, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exclusive cigarette smokers

Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.

Other: All nicotine/ tobacco products at market price
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine vaping products at 1/2 market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine vaping products at 2x market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Heated tobacco products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Heated tobacco products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine pouch products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine pouch products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Experimental: Dual cigarette/ nicotine vaping product users

Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.

Other: All nicotine/ tobacco products at market price
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine vaping products at 1/2 market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine vaping products at 2x market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Heated tobacco products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Heated tobacco products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine pouch products at 1/2 market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Other: Nicotine pouch products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Outcome Measures

Primary Outcome Measures

  1. Nicotine/tobacco products substitution [1 day]

    Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product.

  2. Cigarette demand [1 day]

    Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Provide informed consent

  • Be at least 21 years of age or older

  • Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)

  • Stable tobacco use patterns for at least three months

  • Be willing to sample NVPs, HTPs, and NPPs

  • For exclusive cigarette smokers: smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month)

  • For dual cigarette/NVP users: smoke at least 5 cigarettes daily and use NVPs for at least 3 times in a week (report use of closed nicotine salt system)

Exclusion Criteria:
  • Have plans to move out of the area

  • Have a serious or unstable physical or mental health condition

  • Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement

  • Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fralin Biomedical Research Institute Roanoke Virginia United States 24016

Sponsors and Collaborators

  • Virginia Polytechnic Institute and State University
  • Medical University of South Carolina
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Warren K Bickel, Ph.D., Fralin Biomedical Research Institute at VTC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Warren K. Bickel, Professor and Director, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT05177848
Other Study ID Numbers:
  • IRB #21-1046
  • 5P01CA200512
First Posted:
Jan 5, 2022
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2022