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Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study

Examining the Generality of Laboratory-based Findings and Their Moderators Using Diverse Samples From the International Tobacco Control (ITC) Policy Evaluation Project Cohorts - Study 3a

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06456671
Acronym
MUSC-R 3a
Enrollment
440
Registered
2024-06-13
Start date
2024-07-29
Completion date
2025-01-07
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Nicotine Vaping

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.

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, user type, and regulatory environment. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

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 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 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER
Medical University of South Carolina
CollaboratorOTHER
University of Waterloo
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

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 and market price).

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* From CA, US, or EN * At least 21 years old * Smoking daily * Smoking mostly or about equal amounts of factory-made cigarettes * Does not currently vape (for exclusive smokers only) * Vapes Daily (for dual users only)

Exclusion criteria

* There will be no additional

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Budget Spent - CIGARETTES1 dayParticipants completed purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (nicotine vaping products, heated tobacco products, nicotine pouch products) prices was assessed. Participants completed the ETM task under four within-subject conditions: Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price Within each condition, cigarette prices ascended across 5 trials: Trial Cigarette Price Multiplier 1. 0.5x market price 2. 1.0x market price (reference) 3. 2.0x market price 4. 4.0x market price 5. 8.0x market price Proportion of the budget spent on cigarettes

Secondary

MeasureTime frameDescription
Alternative Product Consumption - E-CIGARETTES1 dayParticipants completed the ETM task under four within-subject conditions: Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price Within each condition, cigarette prices ascended across 5 trials: Trial Cigarette Price Multiplier 1. 0.5x market price 2. 1.0x market price (reference) 3. 2.0x market price 4. 4.0x market price 5. 8.0x market price Data are reported as the number of puffs purchased at each condition and cigarette trial price.
Alternative Product Consumption - HTP1 dayParticipants completed the ETM task under four within-subject conditions: Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price Within each condition, cigarette prices ascended across 5 trials: Trial Cigarette Price Multiplier 1. 0.5x market price 2. 1.0x market price (reference) 3. 2.0x market price 4. 4.0x market price 5. 8.0x market price Data is reported as the quantity purchased of HTP sticks at each condition and cigarette trial price.
Alternative Product Consumption - Nicotine Pouches1 dayParticipants completed the ETM task under four within-subject conditions: Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price Within each condition, cigarette prices ascended across 5 trials: Trial Cigarette Price Multiplier 1. 0.5x market price 2. 1.0x market price (reference) 3. 2.0x market price 4. 4.0x market price 5. 8.0x market price Data are reported as the quantity of nicotine pouches purchased for each condition and cigarette trial price.
Alternative Product Consumption - Nicotine Replacement Therapy1 dayParticipants completed the ETM task under four within-subject conditions: Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price Within each condition, cigarette prices ascended across 5 trials: Trial Cigarette Price Multiplier 1. 0.5x market price 2. 1.0x market price (reference) 3. 2.0x market price 4. 4.0x market price 5. 8.0x market price Data are reported as the quantity of NRT gums/lozenges purchased at each condition and cigarette trial price.
Alternative Product Consumption - Oral Tobacco Products1 dayParticipants completed the ETM task under four within-subject conditions: Control: All products at market price NVP (Nicotine Vaping Products): E-cigarettes at 50% market price NPP (Nicotine Pouches): Nicotine pouches at 50% market price HTP (Heated Tobacco Products): HTPs at 50% market price Within each condition, cigarette prices ascended across 5 trials: Trial Cigarette Price Multiplier 1. 0.5x market price 2. 1.0x market price (reference) 3. 2.0x market price 4. 4.0x market price 5. 8.0x market price Data are reported as the quantity of SNUS/DIP (oral tobacco products) purchased for each condition and cigarette trial price.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORWarren K Bickel, Ph.D.

Fralin Biomedical Research Institute at VTC

Baseline characteristics

Characteristic
Age, Continuous
Canada
43 years
STANDARD_DEVIATION 12
Age, Continuous
United Kingdom
46 years
STANDARD_DEVIATION 12
Age, Continuous
United States
52 years
STANDARD_DEVIATION 14
Education
Canada
High
36 Participants
Education
Canada
Low
27 Participants
Education
Canada
Moderate
73 Participants
Education
Canada
No answer
1 Participants
Education
Canada
Unknown
1 Participants
Education
United Kingdom
High
42 Participants
Education
United Kingdom
Low
10 Participants
Education
United Kingdom
Moderate
53 Participants
Education
United Kingdom
No answer
0 Participants
Education
United Kingdom
Unknown
0 Participants
Education
United States
High
4 Participants
Education
United States
Low
9 Participants
Education
United States
Moderate
39 Participants
Education
United States
No answer
0 Participants
Education
United States
Unknown
0 Participants
Income
Canada
High
67 Participants
Income
Canada
Low
15 Participants
Income
Canada
Moderate
33 Participants
Income
Canada
No answer
5 Participants
Income
Canada
Unknown
1 Participants
Income
United Kingdom
High
22 Participants
Income
United Kingdom
Low
14 Participants
Income
United Kingdom
Moderate
28 Participants
Income
United Kingdom
No answer
0 Participants
Income
United Kingdom
Unknown
0 Participants
Income
United States
High
33 Participants
Income
United States
Low
24 Participants
Income
United States
Moderate
36 Participants
Income
United States
No answer
0 Participants
Income
United States
Unknown
0 Participants
Race/Ethnicity, Customized
Canada
Non-white or non-english speaker
29 Participants
Race/Ethnicity, Customized
Canada
Unknown
2 Participants
Race/Ethnicity, Customized
Canada
White or English speaker
47 Participants
Race/Ethnicity, Customized
United Kingdom
Non-white or non-english speaker
13 Participants
Race/Ethnicity, Customized
United Kingdom
Unknown
0 Participants
Race/Ethnicity, Customized
United Kingdom
White or English speaker
141 Participants
Race/Ethnicity, Customized
United States
Non-white or non-english speaker
26 Participants
Race/Ethnicity, Customized
United States
Unknown
0 Participants
Race/Ethnicity, Customized
United States
White or English speaker
82 Participants
Region of Enrollment
Canada
77 Participants
Region of Enrollment
United Kingdom
77 Participants
Region of Enrollment
United States
114 Participants
Sex: Female, Male
Canada
Female
68 Participants
Sex: Female, Male
Canada
Male
50 Participants
Sex: Female, Male
United Kingdom
Female
70 Participants
Sex: Female, Male
United Kingdom
Male
84 Participants
Sex: Female, Male
United States
Female
58 Participants
Sex: Female, Male
United States
Male
41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2590 / 181
other
Total, other adverse events
0 / 2590 / 181
serious
Total, serious adverse events
0 / 2590 / 181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026