- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946031
Testing the ETM: Examination and Comparison of Different Methods
June 3, 2026 updated by: Jeffrey Stein, Virginia Polytechnic Institute and State University
Testing the Experimental Tobacco Marketplace: Examination and Comparison of Different Methods
This study will experimentally assess the comparability of in-lab and remote procedures with hypothetical and real ETM purchase outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In a between-group within-subject repeated measures design, participants will be randomly assigned to one of two procedures (in-lab or remote; between-group) and complete two conditions (real and hypothetical; within-subject), which include six trials assessing increasing cigarette prices.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provide informed consent
- Be at least 21 years of age or older
- Stable tobacco use patterns for at least three months
- Smoke at least 5 cigarettes daily
- Use other tobacco products less than weekly
- Have access to a computer and internet
Exclusion Criteria:
- report uncontrolled physical or mental health conditions (e.g., uncontrolled diabetes, high blood pressure, major depressive disorder, etc.),
- use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days,
- report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days,
- be pregnant or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: In-lab procedures
Exclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory.
|
Exclusive cigarette smokers will be recruited and will be exposed to the real ETM condition in which tobacco purchases are real and they receive products from one randomly selected trial.
Exclusive cigarette smokers will be recruited and will be exposed to the hypothetical ETM condition in which tobacco purchases are hypothetical and they don't receive any products.
|
|
Experimental: Remote procedures
Exclusive cigarette smokers will be recruited and will experience all study procedures remotely.
|
Exclusive cigarette smokers will be recruited and will be exposed to the real ETM condition in which tobacco purchases are real and they receive products from one randomly selected trial.
Exclusive cigarette smokers will be recruited and will be exposed to the hypothetical ETM condition in which tobacco purchases are hypothetical and they don't receive any products.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cigarette demand
Time Frame: 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 remain constant.
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
|
|
Nicotine/tobacco products substitution
Time Frame: 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 remain constant.
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey Stein, Ph.D., Fralin Biomedical Research Institute at VTC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2024
Primary Completion (Actual)
August 14, 2025
Study Completion (Actual)
August 15, 2025
Study Registration Dates
First Submitted
July 6, 2023
First Submitted That Met QC Criteria
July 6, 2023
First Posted (Actual)
July 14, 2023
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 3, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #24-837
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The study team will share de-identified data upon request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.