Testing the ETM: Examination and Comparison of Different Methods

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05946031

Collaborator

(none)

109

Enrollment

Location

Arms

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking	Behavioral: Reat ETM Behavioral: Hypothetical ETM	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will complete two Experimental Marketplace conditions, representing one with real and one with hypothetical purchasing outcomes. Within each condition, taxes will be increased proportionally across 6 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.Participants will complete two Experimental Marketplace conditions, representing one with real and one with hypothetical purchasing outcomes. Within each condition, taxes will be increased proportionally across 6 trials to examine how cigarette purchasing, substitution, and poly-tobacco purchasing (i.e., diversity in products purchased) are affected.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Dec 15, 2024

Anticipated Study Completion Date :

Dec 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: In-lab procedures Exclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory.	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. Behavioral: 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.
Experimental: Remote procedures Exclusive cigarette smokers will be recruited and will experience all study procedures remotely.	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. Behavioral: 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.

Arm

Intervention/Treatment

Experimental: In-lab procedures

Exclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory.

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.

Behavioral: 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.

Experimental: Remote procedures

Exclusive cigarette smokers will be recruited and will experience all study procedures remotely.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fralin Biomedical Research Institute	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

Virginia Polytechnic Institute and State University

Investigators

Principal Investigator: Warren K Bickel, Ph.D., Fralin Biomedical Research Institute at VTC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Warren K. Bickel, Professor and Director, Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT05946031

Other Study ID Numbers:

IRB #23-734

First Posted:

Jul 14, 2023

Last Update Posted:

Jul 14, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 14, 2023