Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2023
CompletedResults Posted
Study results publicly available
September 26, 2024
CompletedJanuary 30, 2025
August 1, 2024
11 months
December 14, 2021
August 30, 2024
January 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Nicotine/Tobacco Products Substitution
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.
1 day
Cigarette Demand
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.
1 day
Study Arms (2)
Exclusive cigarette smokers
EXPERIMENTALExclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users
EXPERIMENTALDual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.
Interventions
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Roberta Freitas-Lemos
- Organization
- Fralin Biomedical Research Institute at VTC
Study Officials
- PRINCIPAL INVESTIGATOR
Warren K Bickel, Ph.D.
Fralin Biomedical Research Institute at VTC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
- Professor
Study Record Dates
First Submitted
December 14, 2021
First Posted
January 5, 2022
Study Start
June 29, 2022
Primary Completion
June 2, 2023
Study Completion
June 7, 2023
Last Updated
January 30, 2025
Results First Posted
September 26, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share
The study team will share de-identified data upon request.