Testing the ETM: Examination and Comparison of Different Methods

NCT05946031 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB #24-837
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• 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(-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

  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

Study Arms (2)

In-lab procedures

EXPERIMENTAL

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

Drug: Reat ETM; Drug: Hypothetical ETM

Remote procedures

EXPERIMENTAL

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

Drug: Reat ETM; Drug: Hypothetical ETM

Interventions

Reat ETM DRUG

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.

In-lab procedures; Remote procedures

Hypothetical ETM DRUG

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.

In-lab procedures; Remote procedures

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Roberta Freitas-Lemos, Ph.D.

  Fralin Biomedical Research Institute at VTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: July 28, 2024
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: October 2, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)