Testing the ETM: Examination and Comparison of Different Methods

Early Phase 1

Recruiting

• Conditions: Cigarette Smoking
• Interventions: Drug: Reat ETM; Drug: Hypothetical ETM

• Registration Number: NCT05946031
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief Summary

This study will experimentally assess the comparability of in-lab and remote procedures with hypothetical and real ETM purchase outcomes.

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 Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Study Start: 2024-11-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 109

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
In-lab procedures	Reat ETM	Exclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory.
In-lab procedures	Hypothetical ETM	Exclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory.
Remote procedures	Reat ETM	Exclusive cigarette smokers will be recruited and will experience all study procedures remotely.
Remote procedures	Hypothetical ETM	Exclusive cigarette smokers will be recruited and will experience all study procedures remotely.

Primary Outcome Measures

Name	Time	Method
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 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.
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 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.

Trial Locations

Locations (1)

Fralin Biomedical Research Institute; 🇺🇸 Roanoke, Virginia, United States