Cigarette SmokingNCT05177848

Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type

A study testing All nicotine/ tobacco products at market price, Nicotine vaping products at 1/2 market price and Nicotine vaping products at 2x market price in people with Cigarette Smoking and Nicotine Vaping, run by Virginia Polytechnic Institute and State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Cigarette Smoking, Nicotine Vaping
What is being tested?: All nicotine/ tobacco products at market price, Nicotine vaping products at 1/2 market price and Nicotine vaping products at 2x market price
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 29 Jun 2022to 7 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 NVPs, HTPs, and NPPs
For exclusive cigarette smokers: smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month)
For dual cigarette/NVP users: smoke at least 5 cigarettes daily and use NVPs for at least 3 times in a week (report use of closed nicotine salt system)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Fralin Biomedical Research Institute
Roanoke, Virginia, 24016

Other trials in United States

About this study

Read the detailed description

An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products [NVP], heated tobacco products [HTP], and nicotine pouch products [NPP]), and how the appeal is modulated by relative price and user type. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.

Conditions: Cigarette Smoking, Nicotine Vaping
Being tested: All nicotine/ tobacco products at market price, Nicotine vaping products at 1/2 market price, Nicotine vaping products at 2x market price, Heated tobacco products at 1/2 market price., Heated tobacco products at 2x market price.
Medical subject headings: Cigarette Smoking, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

All nicotine/ tobacco products at market priceOther
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Nicotine vaping products at 1/2 market priceOther
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Nicotine vaping products at 2x market priceOther
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Heated tobacco products at 1/2 market price.Other
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Heated tobacco products at 2x market price.Other
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Nicotine pouch products at 1/2 market price.Other
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Nicotine pouch products at 2x market price.Other
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.

Study groups in NCT05177848
Study group	Role	What they receive
Exclusive cigarette smokers	Experimental	Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section. Receives: Other: All nicotine/ tobacco products at market price; Other: Nicotine vaping products at 1/2 market price; Other: Nicotine vaping products at 2x market price; Other: Heated tobacco products at 1/2 market price.; Other: Heated tobacco products at 2x market price.; Other: Nicotine pouch products at 1/2 market price.; Other: Nicotine pouch products at 2x market price.
Dual cigarette/ nicotine vaping product users	Experimental	Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section. Receives: Other: All nicotine/ tobacco products at market price; Other: Nicotine vaping products at 1/2 market price; Other: Nicotine vaping products at 2x market price; Other: Heated tobacco products at 1/2 market price.; Other: Heated tobacco products at 2x market price.; Other: Nicotine pouch products at 1/2 market price.; Other: Nicotine pouch products at 2x market price.

What is being measured

The primary outcome is the main question the study is designed to answer.

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 depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) 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.
Measured: 1 day
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 depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) 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.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20227 Jun 2023

First posted5 Jan 2022
Study start29 Jun 2022
Primary completion2 Jun 2023
Study completion7 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cigarette SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05177848
Sponsor's protocol ID: IRB #21-1046
Other IDs: 5P01CA200512
Status last verified: Aug 2024
First submitted: 14 Dec 2021
Last updated: 30 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The study team will share de-identified data upon request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type
ClinicalTrials.gov ID: NCT05177848
Acronym / sponsor ID: IRB #21-1046
Conditions: Cigarette Smoking, Nicotine Vaping
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
Collaborators: Medical University of South Carolina, National Cancer Institute (NCI)
Study start: 29 Jun 2022 (actual)
Primary completion: 2 Jun 2023 (actual)
Study completion: 7 Jun 2023 (actual)
First posted: 5 Jan 2022 (actual)
Results: Posted 26 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).

Arm	Type	Receives
Exclusive cigarette smokers	Experimental	Other: All nicotine/ tobacco products at market price, Other: Nicotine vaping products at 1/2 market price, Other: Nicotine vaping products at 2x market price, Other: Heated tobacco products at 1/2 market price., Other: Heated tobacco products at 2x market price., Other: Nicotine pouch products at 1/2 market price., Other: Nicotine pouch products at 2x market price.Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Dual cigarette/ nicotine vaping product users	Experimental	Other: All nicotine/ tobacco products at market price, Other: Nicotine vaping products at 1/2 market price, Other: Nicotine vaping products at 2x market price, Other: Heated tobacco products at 1/2 market price., Other: Heated tobacco products at 2x market price., Other: Nicotine pouch products at 1/2 market price., Other: Nicotine pouch products at 2x market price.Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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 NVPs, HTPs, and NPPs

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
All nicotine/ tobacco products at market priceNicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.	Other	Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers
Nicotine vaping products at 1/2 market priceAvailability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.	Other	Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers
Nicotine vaping products at 2x market priceAvailability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.	Other	Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers
Heated tobacco products at 1/2 market price.Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.	Other	Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers
Heated tobacco products at 2x market price.Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.	Other	Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers
Nicotine pouch products at 1/2 market price.Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.	Other	Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers
Nicotine pouch products at 2x market price.Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.	Other	Dual cigarette/ nicotine vaping product users, Exclusive cigarette smokers

Primary outcome

Nicotine/Tobacco Products Substitution
Time frame: 1 day
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) 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
Time frame: 1 day
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) 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.

Results and safety

Results posted to the registry on 26 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exclusive Cigarette Smokers	29	26
Dual Cigarette/ Nicotine Vaping Product Users	31	26

Primary outcome: Nicotine/Tobacco Products Substitution

Time frame: 1 day. Mean (Standard Deviation). Unit: mg of nicotine purchased

Measure	Exclusive Cigarette Smokers n = 26	Dual Cigarette/ Nicotine Vaping Product Users n = 26
Control	12.11 (51.66)	4.82 (25.93)
HTP 1/2	25.28 (45.78)	17.08 (22.07)
HTP 2	19.70 (43.92)	10.73 (24.88)
NPP 1/2	20.77 (52.88)	11.06 (28.00)
NPP 2	16.36 (50.81)	-1.09 (27.51)
NVP 1/2	11.62 (118.50)	-0.68 (81.91)
NVP 2	24.56 (39.38)	11.58 (26.46)

Exclusive Cigarette Smokers vs Dual Cigarette/ Nicotine Vaping Product Users: p = 0.9793, Mixed Models Analysis

Primary outcome: Cigarette Demand

Time frame: 1 day. Mean (Standard Deviation). Unit: mg of nicotine purchased

Measure	Exclusive Cigarette Smokers n = 26	Dual Cigarette/ Nicotine Vaping Product Users n = 26
Control	212.39 (206.92)	193.58 (258.37)
HTP 1/2	221.66 (235.08)	163.28 (170.31)
HTP 2	186.03 (206.94)	231.96 (391.03)
NPP 1/2	229.45 (225.12)	186.18 (200.50)
NPP 2	225.77 (217.11)	163.71 (225.14)
NVP 1/2	187.58 (205.34)	184.45 (229.39)
NVP 2	198.93 (197.99)	237.64 (309.73)

Exclusive Cigarette Smokers vs Dual Cigarette/ Nicotine Vaping Product Users: p = 0.29, Mixed Models Analysis
Exclusive Cigarette Smokers vs Dual Cigarette/ Nicotine Vaping Product Users: p = 0.46, Mixed Models Analysis

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exclusive Cigarette Smokers	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Dual Cigarette/ Nicotine Vaping Product Users	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. The study team will share de-identified data upon request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Warren K Bickel, Ph.D. principal investigator

Fralin Biomedical Research Institute at VTC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nicotine/Tobacco Products Substitution (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05177848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.