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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05487625
Other study ID # IRB #22-432
Secondary ID 5P01CA217806
Status Recruiting
Phase N/A
First received
Last updated
Start date August 8, 2022
Est. completion date May 31, 2024

Study information

Verified date January 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
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effects of narratives on demand for low and high ventilated cigarettes and substitution for alternative products in the Experimental Tobacco Marketplace.


Description:

An important aim of tobacco control is to reduce demand for the most harmful products. One product feature that could be changed to benefit public health is cigarette filter ventilation. A recent review examined the effects of cigarette filter ventilation and concluded that filter ventilation, by changing how a cigarette burns, yields more mutagens and carcinogens, and results in greater puff volume and possibly depth of inhalation, which has led to increases in peripheral lung adenocarcinomas. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to compare the impact of a narrative and a factsheet on the negative consequences of filter ventilation on tobacco product purchases. High-ventilated cigarette smokers will complete multiple scenarios in the ETM.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
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 - Provide a breath sample for measuring carbon monoxide (CO = 8 ppm) - Stable tobacco use patterns for at least three months - Be willing to sample the study cigarettes (high- and low-ventilated cigarettes) - Report smoking a high-ventilated cigarette (>= 20% ventilation) - Report smoking at least 10 cigarettes per day Exclusion Criteria: - Have plans to move out of the area - Have a serious or unstable physical or mental health condition - Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement - Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High-ventilated cigarette alone
High-ventilated cigarettes are the only available cigarettes in the Experimental Tobacco Marketplace which increases in price across trials. Other nicotine/tobacco products are available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Low-ventilated cigarette alone
Low-ventilated cigarettes are the only available cigarettes in the Experimental Tobacco Marketplace which increases in price across trials. Other nicotine/tobacco products are available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
High- and low-ventilated cigarette with high-ventilated cigarettes increasing in price
High- and low ventilated cigarettes are available in the Experimental Tobacco Marketplace with high-ventilated cigarettes increasing in price across trials. Other nicotine/tobacco products are available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Low- and high-ventilated cigarette with high-ventilated cigarettes increasing in price
Low- and high-ventilated cigarettes are available in the Experimental Tobacco Marketplace with low-ventilated cigarettes increasing in price across trials. Other nicotine/tobacco products are available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.
Usual cigarette, low- and high-ventilated cigarettes are available in the Experimental Tobacco Marketplace with usual cigarettes increasing in price across trials. Other nicotine/tobacco products are available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.

Locations

Country Name City State
United States Addiction recovery Research center Roanoke Virginia

Sponsors (3)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University National Cancer Institute (NCI), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nicotine/tobacco products substitution Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price (cigarette type depending on condition). Other product prices will remain at market price. The degree to which other nicotine/tobacco products substitute for usual, high-and-low ventilated cigarettes prices will be assessed.
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
Primary Cigarette demand Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price (cigarette type depending on condition). Other product prices will remain at market price. The degree to which other nicotine/tobacco products substitute for usual, high-and-low ventilated cigarettes prices will be assessed.
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
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