- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05487625
Effects of Narratives on Demand for Low and High Ventilated Cigarettes and Substitution for Alternative Products
Study Overview
Status
Conditions
Intervention / Treatment
- 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.
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roberta Freitas Lemos, Ph.D.
- Phone Number: 5405262106
- Email: rflemos@vtc.vt.edu
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Recruiting
- Addiction recovery Research center
-
Contact:
- Kirstin Gatchalian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 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 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 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 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.
|
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 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 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 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 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.
|
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 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 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 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nicotine/tobacco products substitution
Time Frame: 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. |
1 day
|
Cigarette demand
Time Frame: 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. |
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Warren K Bickel, Ph.D., Fralin Biomedical Research Institute at VTC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB #22-432
- 5P01CA217806 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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