Health CommunicationNCT05506046
Messages About Reduced Nicotine in Combusted Tobacco Products
A study testing Reduced nicotine message exposure, Modified risk message exposure and Combined message exposure (reduced nicotine + modified risk) in people with Health Communication and Smoking, run by Georgia State University at 1 site in United States.
Trial summary
The investigators will conduct a message-exposure experiment with nationally representative samples of smokers, dual-users (cigarettes and e-cigarettes), and young adult non-smokers (aged 18-29). Experimental messages will address the reduction of nicotine in cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Communication, Smoking, Smoking, Tobacco
- What is being tested?
- Reduced nicotine message exposure, Modified risk message exposure and Combined message exposure (reduced nicotine + modified risk)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,901 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 28 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years old or older:
- Belonging to one of three groups of participants; 900 current exclusive smokers, 450 dual users (cigarettes and e-cigarettes), and 450 young adult (18-29) non-smokers, evenly split between men and women.
- Enrolled in existing nationally representative panel where recruitment is based
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Messages About Reduced Nicotine in Combusted Tobacco Products: An Online Randomized Controlled Trial
The investigators will conduct a message-exposure experiment with nationally representative samples of smokers, dual-users (cigarettes and e-cigarettes), and young adult non-smokers (aged 18-29).
Experimental messages will address the reduction of nicotine in cigarettes. Participants will also complete a follow-up survey after 2 weeks, measuring their recall of the messages and behaviors since message exposure.
Read the detailed description
A national probability-based sample will be recruited to include 900 current exclusive smokers, 450 dual users, and 450 young adult (18-29) non-smokers, evenly split between men and women.
The study will be conducted using a self-administered, online questionnaire via proprietary, web-assisted interviewing software.
Participants are randomized to one of four conditions:
- reduced nicotine messages
- modified risk messages
- a combination of reduced nicotine message and modified risk message
- control messages with no cigarette-related content
Participants will take part in two sessions: in session 1 (estimated at about 15 min) participants will see the messages and report immediate outcomes including risk perceptions.
In session 2, which will take place 2 weeks after session 1, participants will complete a brief 5-minute survey measuring their recall of the messages and behaviors since message exposure.
- Being tested
- Reduced nicotine message exposure, Modified risk message exposure, Combined message exposure (reduced nicotine + modified risk), Control message exposure
- Medical subject headings
- Smoking, Tobacco Smoking, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced nicotine message exposureBehavioural
Participants will be shown two messages about harms of reduced nicotine cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that reduced nicotine cigarettes will still have the rest of the harmful chemicals and cause diseases as the regular cigarettes, but they would make it easier to quit.
Modified risk message exposureBehavioural
Participants will be shown two messages about electronic cigarettes as an alternative to regular cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that electronic cigarettes are less likely than regular cigarettes to cause severe diseases such as lung cancer.
Combined message exposure (reduced nicotine + modified risk)Behavioural
Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set.
Control message exposureBehavioural
Participants will be shown two messages about drinking bottled water. These will be selected from a pool of five message. The messages display specific water products and describe hydration as a healthy activity.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Nicotine Messages | Experimental | Participants will receive messages with information about reduced nicotine cigarettes. Receives: Behavioral: Reduced nicotine message exposure |
| Modified Risk Messages | Experimental | Participants will receive messages with information about e-cigarettes. Receives: Behavioral: Modified risk message exposure |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Experimental | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. Receives: Behavioral: Combined message exposure (reduced nicotine + modified risk) |
| Control | Other | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Receives: Behavioral: Control message exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Health Risk of VLNCs (Absolute)
Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Measured: Immediately after exposure
Secondary outcomes (8)
Interest in Trying Reduced Nicotine Cigarettes
A single item measuring how interested a participant is in trying reduced nicotine cigarettes. Response options are from 1 (not at all) to 7 (extremely), with higher scores representing a worse outcome. An additional option, "Don't know", is also provided.
Measured: Immediately after exposure
Intention to Switch From Cigarettes to Electronic Nicotine Products
A single item measuring intention (during the next 6 months) to switch completely from cigarettes to electronic nicotine products. Response options are from 1 (not at all likely) to 7 (extremely likely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Measured: Immediately after exposure
Perceived Addictiveness of VLNCs
A single item measuring participants' perception of likelihood of developing addiction to reduced nicotine cigarettes under conditions of smoking them every day. Response options are from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a worse outcome. An additional option, "Don't know", is also provided.
Measured: Immediately after exposure
VLNC Comparative Risk Perceptions
A single item measuring perceptions of comparative risk of smoking reduced nicotine cigarettes vs regular cigarettes. Response options are from 1 (Much less harmful) to 5 (Much more harmful), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Measured: Immediately after exposure
VLNC Policy Support
A single item measuring support for the policy to reduce nicotine by 95% in all cigarettes. Response options are from 1 (Strongly Oppose) to 5 (Strongly Support), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Measured: Immediately after exposure
Perceived Message Effectiveness
A three-item scale measuring to what extent participants think the messages they saw discourage them from wanting to smoke, make smoking seem unpleasant, and make them concerned about health risks of smoking.
Response options: from 1 (Disagree) to 4 (Neither Disagree nor Agree) to 7 (Strongly Agree).
Higher scores represent a better outcome. The final perceived message effectiveness score is the mean of the response to the three items.
Measured: Immediately after exposure
Perceived Health Risk of VLNCs (Absolute) at Post-test
Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
Measured: Two weeks after exposure
Smoking Behavior
Single item measuring the average number of cigarettes smoked per day in the past two weeks.
Measured: Two weeks after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start12 Oct 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health CommunicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyudmila Popova, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506046
- Sponsor's protocol ID
- H22639
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2022
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pei D, Reynolds RM, Ntansah CA, Hackworth EE, Henderson KC, Yang B, Duong HT, Ashley DL, Thrasher JF, Popova L. Independent and combined effects of very low nicotine cigarette messages and e-cigarette messages: a randomised clinical trial. Tob Control. 2025 Dec 19;34(e1):e48-e56. doi: 10.1136/tc-2023-058556.
PubMed 38664002
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Messages About Reduced Nicotine in Combusted Tobacco Products: An Online Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05506046
- Acronym / sponsor ID
- H22639
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,901 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a message-exposure experiment with nationally representative samples of smokers, dual-users (cigarettes and e-cigarettes), and young adult non-smokers (aged 18-29).
Experimental messages will address the reduction of nicotine in cigarettes. Participants will also complete a follow-up survey after 2 weeks, measuring their recall of the messages and behaviors since message exposure.
Detailed description
A national probability-based sample will be recruited to include 900 current exclusive smokers, 450 dual users, and 450 young adult (18-29) non-smokers, evenly split between men and women.
The study will be conducted using a self-administered, online questionnaire via proprietary, web-assisted interviewing software.
Participants are randomized to one of four conditions:
- reduced nicotine messages
- modified risk messages
- a combination of reduced nicotine message and modified risk message
- control messages with no cigarette-related content
Participants will take part in two sessions: in session 1 (estimated at about 15 min) participants will see the messages and report immediate outcomes including risk perceptions.
In session 2, which will take place 2 weeks after session 1, participants will complete a brief 5-minute survey measuring their recall of the messages and behaviors since message exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reduced Nicotine Messages | Experimental | Behavioral: Reduced nicotine message exposureParticipants will receive messages with information about reduced nicotine cigarettes. |
| Modified Risk Messages | Experimental | Behavioral: Modified risk message exposureParticipants will receive messages with information about e-cigarettes. |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Experimental | Behavioral: Combined message exposure (reduced nicotine + modified risk)Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. |
| Control | Other | Behavioral: Control message exposureParticipants will receive messages about bottled water which should have no impact on the outcomes of interest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years old or older:
- Belonging to one of three groups of participants; 900 current exclusive smokers, 450 dual users (cigarettes and e-cigarettes), and 450 young adult (18-29) non-smokers, evenly split between men and women.
- Enrolled in existing nationally representative panel where recruitment is based
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Reduced nicotine message exposureParticipants will be shown two messages about harms of reduced nicotine cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that reduced nicotine cigarettes will still have the rest of the harmful chemicals and cause diseases as the regular cigarettes, but they would make it easier to quit. | Behavioural | Reduced Nicotine Messages |
| Modified risk message exposureParticipants will be shown two messages about electronic cigarettes as an alternative to regular cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that electronic cigarettes are less likely than regular cigarettes to cause severe diseases such as lung cancer. | Behavioural | Modified Risk Messages |
| Combined message exposure (reduced nicotine + modified risk)Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set. | Behavioural | Combined Message -- Reduced Nicotine + Modified Risk Exposure |
| Control message exposureParticipants will be shown two messages about drinking bottled water. These will be selected from a pool of five message. The messages display specific water products and describe hydration as a healthy activity. | Behavioural | Control |
Primary outcome
Perceived Health Risk of VLNCs (Absolute)
Time frame: Immediately after exposure
Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, "Don't know", is also provided.
8 secondary outcomes
Interest in Trying Reduced Nicotine Cigarettes
Time frame: Immediately after exposure
Intention to Switch From Cigarettes to Electronic Nicotine Products
Time frame: Immediately after exposure
Perceived Addictiveness of VLNCs
Time frame: Immediately after exposure
VLNC Comparative Risk Perceptions
Time frame: Immediately after exposure
VLNC Policy Support
Time frame: Immediately after exposure
Perceived Message Effectiveness
Time frame: Immediately after exposure
Perceived Health Risk of VLNCs (Absolute) at Post-test
Time frame: Two weeks after exposure
Smoking Behavior
Time frame: Two weeks after exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38664002Pei D, Reynolds RM, Ntansah CA, Hackworth EE, Henderson KC, Yang B, Duong HT, Ashley DL, Thrasher JF, Popova L. Independent and combined effects of very low nicotine cigarette messages and e-cigarette messages: a randomised clinical trial. Tob Control. 2025 Dec 19;34(e1):e48-e56. doi: 10.1136/tc-2023-058556.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced nicotine message exposure, Modified risk message exposure and Combined message exposure (reduced nicotine + modified risk) in people with Health Communication and Smoking, run by Georgia State University at 1 site in United States.
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 3 inclusion and 1 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 28 Aug 2024. 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 28 Aug 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?
Perceived Health Risk of VLNCs (Absolute) (time frame: Immediately after exposure). 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 NCT05506046, which also lists 1 linked publication.
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 28 Aug 2024.