Effects of Narratives on Demand for Low and High Ventilated Cigarettes and Substitution for Alternative Products

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05487625

Collaborator

University of Minnesota (Other), National Cancer Institute (NCI) (NIH)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking	Behavioral: High-ventilated cigarette alone Behavioral: Low-ventilated cigarette alone Behavioral: High- and low-ventilated cigarette with high-ventilated cigarettes increasing in price Behavioral: Low- and high-ventilated cigarette with high-ventilated cigarettes increasing in price Behavioral: Usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Participants will complete five ETM conditions, which include six trials assessing different cigarette prices: a) high-ventilated cigarette alone, b) low-ventilated cigarette alone, c) high- and low-ventilated cigarette with high-ventilated cigarettes increasing in price, d) high- and low-ventilated cigarette with low-ventilated cigarettes increasing in price, and e) usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.Participants will complete five ETM conditions, which include six trials assessing different cigarette prices: a) high-ventilated cigarette alone, b) low-ventilated cigarette alone, c) high- and low-ventilated cigarette with high-ventilated cigarettes increasing in price, d) high- and low-ventilated cigarette with low-ventilated cigarettes increasing in price, and e) usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.

Masking:

Single (Participant)

Masking Description:

Participants will be provided with study cigarettes (commercially available) however the brand will not be provided to them.

Primary Purpose:

Basic Science

Official Title:

Effects of Narratives on Demand for Low and High Ventilated Cigarettes and Substitution for Alternative Products

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Narratives High-ventilated cigarette smokers will be exposed to a narrative about the negative consequences of smoking ventilated cigarettes and all of the conditions described in the intervention section.	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. Behavioral: 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. Behavioral: 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. Behavioral: 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. Behavioral: 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.
Experimental: Fact sheet High-ventilated cigarette smokers will be exposed to fact sheet about the negative consequences of smoking ventilated cigarettes and all of the conditions described in the intervention section.	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. Behavioral: 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. Behavioral: 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. Behavioral: 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. Behavioral: 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.
Experimental: Control High-ventilated cigarette smokers will be not be exposed to any messages and will complete all of the conditions described in the intervention section.	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. Behavioral: 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. Behavioral: 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. Behavioral: 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. Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Narratives

High-ventilated cigarette smokers will be exposed to a narrative about the negative consequences of smoking ventilated cigarettes and all of the conditions described in the intervention section.

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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Behavioral: 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.

Experimental: Fact sheet

High-ventilated cigarette smokers will be exposed to fact sheet about the negative consequences of smoking ventilated cigarettes and all of the conditions described in the intervention section.

Behavioral: High-ventilated cigarette alone

Behavioral: Low-ventilated cigarette alone

Behavioral: High- and low-ventilated cigarette with high-ventilated cigarettes increasing in price

Behavioral: Low- and high-ventilated cigarette with high-ventilated cigarettes increasing in price

Behavioral: Usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.

Experimental: Control

High-ventilated cigarette smokers will be not be exposed to any messages and will complete all of the conditions described in the intervention section.

Behavioral: High-ventilated cigarette alone

Behavioral: Low-ventilated cigarette alone

Behavioral: High- and low-ventilated cigarette with high-ventilated cigarettes increasing in price

Behavioral: Low- and high-ventilated cigarette with high-ventilated cigarettes increasing in price

Behavioral: Usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.

Outcome Measures

Primary Outcome Measures

Nicotine/tobacco products substitution [1 day]
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.
Cigarette demand [1 day]
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(-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.

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
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Virginia Polytechnic Institute and State University
University of Minnesota
National Cancer Institute (NCI)

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:

NCT05487625

Other Study ID Numbers:

IRB #22-432
5P01CA217806

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

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 Aug 10, 2022