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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Nicotine Messages | Experimental | Participants will receive messages with information about reduced nicotine cigarettes. |
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| Modified Risk Messages | Experimental | Participants will receive messages with information about e-cigarettes. |
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| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Experimental | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. |
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| Control | Other | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced nicotine message exposure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after exposure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after exposure |
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Inclusion Criteria:
Exclusion Criteria:
- None.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30302 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38664002 | Derived | 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. |
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The panel sample (probability sample) included 971 adults who smoked exclusively, 240 adults who dual used cigarettes and e-cigarettes, and 458 young adults (18-29 years old) who never smoked. To augment the sample of adults who dual used, additional participants were recruited from the opt-in, non-probability sample (n=232) bringing the total sample size to 1901.
Participants were recruited through a panel. Participants were pre-identified based on internal data on age and smoking status: adults who exclusively smoked cigarettes, adults who dual used cigarettes and e-cigarettes, and young adults (aged 18-29) who never smoked.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduced Nicotine Messages | Participants will receive messages with information about reduced nicotine cigarettes. Reduced nicotine message exposure: 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2024 |
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| Modified risk message exposure | Behavioral | 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. |
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| Combined message exposure (reduced nicotine + modified risk) | Behavioral | Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set. |
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| Control message exposure | Behavioral | 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. |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | Two weeks after exposure |
| Smoking Behavior | Single item measuring the average number of cigarettes smoked per day in the past two weeks. | Two weeks after exposure |
| FG001 | Modified Risk Messages | Participants will receive messages with information about e-cigarettes. Modified risk message exposure: 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. |
| FG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| FG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| Compete Session 1 | Number of participants who completed session 1 |
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| Started Session 2 | Number of participants who started session 2 |
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| COMPLETED | number of participants who completed session 2 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduced Nicotine Messages | Participants will receive messages with information about reduced nicotine cigarettes. Reduced nicotine message exposure: 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. |
| BG001 | Modified Risk Messages | Participants will receive messages with information about e-cigarettes. Modified risk message exposure: 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. |
| BG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| BG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants analyzed included all participants in each condition who responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Immediately after exposure |
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| Secondary | 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. | The number of participants analyzed included all participants in each condition who responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Immediately after exposure |
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| Secondary | 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. | The number of participants analyzed included participants who 1) are adults who smoked exclusively and adults who dual used and 2) responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Immediately after exposure |
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| Secondary | 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. | The number of participants analyzed included all participants in each condition who responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Immediately after exposure |
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| Secondary | 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. | The number of participants analyzed included all participants in each condition who responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Immediately after exposure |
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| Secondary | 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. | The number of participants analyzed included all participants in each condition who responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Immediately after exposure |
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| Secondary | 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. | The number of participants analyzed included all participants who responded to all three outcome measures. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Immediately after exposure |
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| Secondary | 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. | The analysis population included participants in each condition that responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Two weeks after exposure |
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| Secondary | Smoking Behavior | Single item measuring the average number of cigarettes smoked per day in the past two weeks. | The number of participants analyzed included participants who 1) are adults who smoked exclusively and adults who dual used and 2) responded to the outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | number of cigarettes/day | Two weeks after exposure |
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Low risk study, no adverse events data collected.
Low risk study, no adverse events data collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced Nicotine Messages | Participants will receive messages with information about reduced nicotine cigarettes. Reduced nicotine message exposure: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Modified Risk Messages | Participants will receive messages with information about e-cigarettes. Modified risk message exposure: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyudmila Popova | Georgia State University | 404-413-9338 | lpopova1@gsu.edu |
| Aug 8, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2022 | Aug 8, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| 30-44 years |
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| 45-59 years |
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| 60+ |
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| Male |
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| Black, non-Hispanic |
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| Other, non-Hispanic |
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| Hispanic |
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| Two Races or more, non-Hispanic |
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| OG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| OG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| OG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| OG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| OG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| OG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| OG002 | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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| Combined Message -- Reduced Nicotine + Modified Risk Exposure |
Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes. 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. |
| OG003 | Control | Participants will receive messages about bottled water which should have no impact on the outcomes of interest. Control message exposure: 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. |
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