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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA051001 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed in waves over 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use.
This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed for 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use. All participants will be recruited from a US national consumer research panel. Eligible participants will be U.S. adults ages 18+ who are enrolled members of the partnering consumer research panel. The sample will include non-smokers and smokers, oversampling current smokers (defined as smoking 100+ lifetime cigarettes and now smoking all or some days) to ensure the proportion of smokers in the sample reflects the ~15 % population smoking prevalence among adults. Panel members will be contacted by email with a brief study description and link to an eligibility screener and online informed consent form. Eligible and interested participants will complete the baseline (Wave 1) survey measures of nicotine beliefs and intentions/use of nicotine and tobacco products, after which they will be randomly assigned in equal numbers to the nicotine corrective message (NCM) intervention condition or the delayed message control condition. After completing the baseline survey, participants in the NCM condition will receive their first exposure to the corrective messages. In the Wave 2 survey, all participants will complete measures of nicotine beliefs and intentions/use of nicotine and tobacco products. Participants in the NCM condition will then receive their second exposure to study messages. Only participants in the NCM condition will receive the Wave 3 survey, which involves the third exposure to study messages. The Wave 4 survey will include the fourth exposure to study messages for those in the NCM condition and the final assessment of nicotine beliefs and intentions/use of nicotine and tobacco products for all participants. Upon completion of the final assessment, participants in the control condition will be exposed to the nicotine corrective messages and all participants will be directed to resources on quitting smoking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Corrective Messages | Experimental | Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes. |
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| Delayed Message Control | No Intervention | Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Corrective Messages | Behavioral | Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes. |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Beliefs | 3 items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarette false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs. | Wave 4 (weeks 11-13) |
| Measure | Description | Time Frame |
|---|---|---|
| Intention to Use Nicotine/Tobacco Products | Four items assessing intention to use tobacco cigarettes, e-cigarettes, NRT, and RNC cigarettes during the next 12 months. Adapted from PhenX Toolkit- Susceptibility to Tobacco Products, response options Definitely Yes; Probably Yes; Probably Not; Definitely Not. Outcomes reported for participants reporting Definitely Yes or Probably Yes to each item. | Wave 4 (weeks 11-13) |
| Measure | Description | Time Frame |
|---|---|---|
| Attitudes About Nicotine | Three items on nicotine-related attitudes using semantic differentials across five-point Likert scales. 'Using Nicotine is:' Safe (1) - Dangerous (5); Positive (1) - Negative (5); Good (1) - Bad (5). | Wave 4 (weeks 11-13) |
| Nicotine Related Norms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea C Villanti, PhD, MPH | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37989586 | Derived | Villanti AC, Peasley-Miklus C, Mercincavage M, Mays D, Donny EC, Cappella JN, Strasser AA. Effect of nicotine corrective messaging on nicotine-related beliefs in US adults: a randomised controlled trial. Tob Control. 2025 Apr 1;34(2):162-168. doi: 10.1136/tc-2023-058252. |
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De-identified participant data from study surveys will be made available upon request and according to access criteria after completion of the study and publication of primary findings.
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After completion of the study and publication of the primary findings, for a period up to 2 years.
A data sharing agreement will be required for release of any data. Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval with FWA information, investigator training in human subjects and other approvals specific to the individual datasets. They will also be required to submit a Data Protection Plan or Institutional Privacy Policy, describing the computing environment in which data will be managed and analyzed and how physical access to computing equipment will be controlled. Data will only be released once all IRB approvals and Human Subjects concerns have been addressed. The PI (A. Villanti) will be required to participate as an investigator on any project requiring data sharing.
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Participants were 794 U.S. English-speaking adults aged 18 and older recruited in spring 2021 from the AmeriSpeak® national consumer market research panel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Corrective Messages | Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes. Nicotine Corrective Messages: Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes. |
| FG001 | Delayed Message Control | Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Corrective Messages | Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes. |
| 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 |
| 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 | Nicotine Beliefs | 3 items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarette false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs. | Posted | Mean | Standard Deviation | score on a scale | Wave 4 (weeks 11-13) |
|
12 weeks
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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 | Nicotine Corrective Messages | Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Villanti | Rutgers Center for Tobacco Studies | 732 235 9585 | andrea.villanti@rutgers.edu |
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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 | Dec 18, 2020 | Nov 15, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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The intervention consists of 8 brief nicotine corrective public education messages delivered online. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.
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| Tobacco Use | Number of days used tobacco in the past 30 days. Days used summed across eight different nicotine/tobacco products (e.g., tobacco cigarettes, e-cigarettes, cigars, NRT, RNC cigarettes). | Wave 4 (weeks 11-13) |
Two items: "How would you describe most people's opinion of using nicotine?" and "Thinking about the people who are important to you, how would you describe their opinion on using nicotine?" with five-point Likert scale responses ranging from "very negative" (1) to "very positive" (5). Higher scores indicate positive norms of using nicotine. |
| Wave 4 (weeks 11-13) |
| Behavioral Control | One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident). | Wave 4 (weeks 11-13) |
| BG001 | Delayed Message Control | Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study. |
| BG002 | Total | Total of all reporting groups |
| 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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| Any past 30-day tobacco use | Count of Participants | Participants |
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| OG001 | Delayed Message Control | Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study. |
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| Secondary | Intention to Use Nicotine/Tobacco Products | Four items assessing intention to use tobacco cigarettes, e-cigarettes, NRT, and RNC cigarettes during the next 12 months. Adapted from PhenX Toolkit- Susceptibility to Tobacco Products, response options Definitely Yes; Probably Yes; Probably Not; Definitely Not. Outcomes reported for participants reporting Definitely Yes or Probably Yes to each item. | The number of participants analyzed differs from the overall number due to item non-response. | Posted | Count of Participants | Participants | Wave 4 (weeks 11-13) |
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| Secondary | Tobacco Use | Number of days used tobacco in the past 30 days. Days used summed across eight different nicotine/tobacco products (e.g., tobacco cigarettes, e-cigarettes, cigars, NRT, RNC cigarettes). | Analyses restricted to participants who reported any past 30-day tobacco use at baseline. | Posted | Mean | Standard Deviation | Days | Wave 4 (weeks 11-13) |
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| Other Pre-specified | Attitudes About Nicotine | Three items on nicotine-related attitudes using semantic differentials across five-point Likert scales. 'Using Nicotine is:' Safe (1) - Dangerous (5); Positive (1) - Negative (5); Good (1) - Bad (5). | The analytic sample differs from the overall sample due to item non-response. | Posted | Mean | Standard Deviation | score on a scale | Wave 4 (weeks 11-13) |
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| Other Pre-specified | Nicotine Related Norms | Two items: "How would you describe most people's opinion of using nicotine?" and "Thinking about the people who are important to you, how would you describe their opinion on using nicotine?" with five-point Likert scale responses ranging from "very negative" (1) to "very positive" (5). Higher scores indicate positive norms of using nicotine. | The analytic sample differs from the overall sample due to item non-response. | Posted | Mean | Standard Deviation | score on a Likert scale | Wave 4 (weeks 11-13) |
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| Other Pre-specified | Behavioral Control | One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident). | Posted | Mean | Standard Deviation | score on a scale | Wave 4 (weeks 11-13) |
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| 0 |
| 393 |
| 0 |
| 393 |
| 0 |
| 393 |
| EG001 | Delayed Message Control | Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study. | 0 | 401 | 0 | 401 | 0 | 401 |
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| E-cigarette/vape |
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| Nicotine replacement product |
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| Low nicotine cigarette |
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| Positive to Negative |
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| Good to Bad |
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| Most people |
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