Examining the Generality of Laboratory-based Findings and Their Moderators in the ITC Study
MUSC-R 3a
2 other identifiers
interventional
440
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 P75+ for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
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
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 7, 2025
CompletedResults Posted
Study results publicly available
April 22, 2026
CompletedApril 22, 2026
March 1, 2026
5 months
June 7, 2024
March 11, 2026
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Budget Spent - CIGARETTES
Participants 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
1 day
Secondary Outcomes (5)
Alternative Product Consumption - E-CIGARETTES
1 day
Alternative Product Consumption - HTP
1 day
Alternative Product Consumption - Nicotine Pouches
1 day
Alternative Product Consumption - Nicotine Replacement Therapy
1 day
Alternative Product Consumption - Oral Tobacco Products
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 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.
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Polytechnic Institute and State Universitylead
- Medical University of South Carolinacollaborator
- University of Waterloocollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roberta Freitas-Lemos
- Organization
- Virginia Polytechnic Institute and State University
Study Officials
- PRINCIPAL INVESTIGATOR
Warren K Bickel, Ph.D.
Fralin Biomedical Research Institute at VTC
Publication Agreements
- PI is Sponsor Employee
- Yes
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
June 7, 2024
First Posted
June 13, 2024
Study Start
July 29, 2024
Primary Completion
January 7, 2025
Study Completion
January 7, 2025
Last Updated
April 22, 2026
Results First Posted
April 22, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
The study team will share de-identified data upon request.