NCT05487625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 8, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 2, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

July 31, 2022

Results QC Date

March 17, 2025

Last Update Submit

June 12, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Nicotine/Tobacco Products Substitution Intercept

    Participants completed purchasing trials in an Experimental Tobacco Marketplace (ETM), where cigarette prices increased (type varied by condition) while other product prices remained at market value. The extent to which other nicotine/tobacco products substituted for usual, high-, and low-ventilated cigarettes was assessed. The quantity of products purchased in the ETM was converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators used ordinary least squares regression to predict total mg of nicotine purchased of the price constant product. Y-intercept of price-constant products is reported.

    1 day

  • Cigarette Demand Intensity q0

    Participants completed purchasing trials in an Experimental Tobacco Marketplace (ETM), where cigarette prices increased (type varied by condition) while other product prices remained at market value. The extent to which other nicotine/tobacco products substituted for usual, high-, and low-ventilated cigarettes was assessed. The quantity of products purchased in the ETM was converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand was estimated using the exponential equation: Q = Q0 \* 10\^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Intensity q0 is reported, which represents the estimated mg of nicotine purchased when cigarettes are free (price = 0).

    1 day

  • Nicotine/Tobacco Products Substitution Slope

    Participants completed purchasing trials in an Experimental Tobacco Marketplace (ETM), where cigarette prices increased (type varied by condition) while other product prices remained at market value. The extent to which other nicotine/tobacco products substituted for usual, high-, and low-ventilated cigarettes was assessed. The quantity of products purchased in the ETM was converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators used ordinary least squares regression to predict total mg of nicotine purchased of the price-constant product. Slope of price-constant products is reported, which represents the change in mg of nicotine purchased of price-constant products divided by the change in cigarette price.

    1 day

  • Cigarette Demand Elasticity Alpha

    Participants completed purchasing trials in an Experimental Tobacco Marketplace (ETM), where cigarette prices increased (type varied by condition) while other product prices remained at market value. The extent to which other nicotine/tobacco products substituted for usual, high-, and low-ventilated cigarettes was assessed. The quantity of products purchased in the ETM was converted to milligrams (mg) of nicotine to standardize the unit of measurement across products. The data reflect the relationship between nicotine purchased (mg; y-axis) and cigarette price (x-axis). Demand was estimated using the exponential equation: Q = Q0 \* 10\^k(exp(-αQ0C) - 1), where Q is nicotine purchased (mg), C is price, Q0 is demand intensity (purchases at no cost), k is the function's logarithmic span, and α is demand elasticity. Elasticity alpha is reported, which represents the sensitivity of purchasing to changes in cigarette price.

    1 day

Study Arms (3)

Narratives

EXPERIMENTAL

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 aloneBehavioral: Low-ventilated cigarette aloneBehavioral: High- and low-ventilated cigarette with high-ventilated cigarettes increasing in priceBehavioral: Low- and high-ventilated cigarette with high-ventilated cigarettes increasing in priceBehavioral: Usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.

Fact sheet

EXPERIMENTAL

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 aloneBehavioral: Low-ventilated cigarette aloneBehavioral: High- and low-ventilated cigarette with high-ventilated cigarettes increasing in priceBehavioral: Low- and high-ventilated cigarette with high-ventilated cigarettes increasing in priceBehavioral: Usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.

Control

EXPERIMENTAL

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 aloneBehavioral: Low-ventilated cigarette aloneBehavioral: High- and low-ventilated cigarette with high-ventilated cigarettes increasing in priceBehavioral: Low- and high-ventilated cigarette with high-ventilated cigarettes increasing in priceBehavioral: Usual, high- and low-ventilated cigarette with usual cigarettes increasing in price.

Interventions

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.

ControlFact sheetNarratives

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.

ControlFact sheetNarratives

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.

ControlFact sheetNarratives

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.

ControlFact sheetNarratives

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.

ControlFact sheetNarratives

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Note: Participants may be withdrawn from the study after providing consent if they submit an invalid breath sample (CO ≥ 8 ppm).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction recovery Research center

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Commerce

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Results Point of Contact

Title
Roberta Freitas Lemos
Organization
Fralin Biomedical Research Institute at VTC

Study Officials

  • Warren K Bickel, Ph.D.

    Fralin Biomedical Research Institute at VTC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be provided with study cigarettes (commercially available) however the brand will not be provided to them.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 4, 2022

Study Start

August 8, 2022

Primary Completion

March 19, 2024

Study Completion

March 26, 2024

Last Updated

July 2, 2025

Results First Posted

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The study team will share de-identified data upon request.

Locations