Testing the ETM: Examination and Comparison of Different Methods

Cigarette Smoking Clinical Trial

Official title:

Testing the Experimental Tobacco Marketplace: Examination and Comparison of Different Methods

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05946031
• Other study ID #: IRB #23-734
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Roberta Freitas Lemos, Ph.D.
• Phone: 5405262106
• Email: rflemos[@]vtc.vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 109
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Reat ETM
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.
• Hypothetical ETM
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.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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(-aQ0C)-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 a is the demand elasticity.	1 day
Primary	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 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