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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA051001 | U.S. NIH Grant/Contract | View source | |
| 849654 | Other Identifier | University of Pennsylvania IRB |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
| National Institute on Drug Abuse (NIDA) | NIH |
| Rutgers University | OTHER |
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The purpose of this study is to examine the effect of nicotine messaging and nicotine content of study cigarettes on nicotine beliefs and subsequent use of tobacco and nicotine products.
This project will utilize a randomized, factorial design trial to examine the effects of nicotine messaging on nicotine harm beliefs and smoking behavior. After a 7-day period of smoking own preferred brand cigarettes, participants will begin a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes. The investigators will aim to recruit and randomize 160 current, daily cigarette smokers (80 male, 80 female) in a 35-day protocol. Participants will be asked to attend 6 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 7, 14, 21, 28 & 35. Sessions will occur every 6-8 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Corrective Messaging | Experimental | After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session. |
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| Delayed Control Messaging | Experimental | After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will not view nicotine messaging until the final study session (Delayed Control Messaging). |
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| Normal Nicotine Content (NNC) cigarettes | Experimental | After completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive normal nicotine content cigarettes. |
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| Reduced Nicotine Content (RNC) cigarettes | Experimental | After completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content cigarettes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Messaging | Other | After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session or delayed control messaging at the final study session. |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Beliefs | Nicotine belief measures will be assessed by participant self-report and comprised of four broad constructs (nicotine beliefs, NRT beliefs, e-cigarette beliefs, and RNC cigarette beliefs). Nicotine beliefs relate specifically to its addictive nature, nicotine as a cause of cancer, and the role of nicotine in the health harms and cancer caused by smoking. The product-specific constructs (i.e., NRT, e-cigarette, RNC cigarette) include items related to the addictiveness of the product and the perceived health risks of the product compared to regular cigarettes. Three 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) cigarettes 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. | Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Cigarette Consumption | Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters. | Day 35 |
| Puff Duration | Total puff duration, the sum of all puff durations per cigarette, will be collected using a standardized video scoring procedure. Participants will be video recorded while smoking each lab cigarette in order to collect smoking topography data. |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Control | One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident). | Day 35 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Additional, general reasons for exclusion include:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Strasser, Ph.D. | University of Pennsylvania | Principal Investigator |
| Andrea Villanti, Ph.D. | Rutgers University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interdisciplinary Research for Nicotine Addiction | Philadelphia | Pennsylvania | 19104 | United States |
Of 99 participants screened eligible between 3/1/2022 and 6/20/2024, 75% (N = 74) were randomized to one of the four study conditions.
This study enrolled adults who currently smoke cigarettes daily from the Philadelphia, PA region. The last participant completed on June 20, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will receive normal nicotine content cigarettes, but will not view nicotine messaging until the final study session. |
| FG001 | Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will receive reduced nicotine content cigarettes, but will not view nicotine messaging until the final study session. |
| FG002 | Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes. |
| FG003 | Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will receive normal nicotine content cigarettes, but will not view nicotine messaging until the final study session. |
| BG001 | Experimental: Delayed Control Messaging + Reduced Nicotine Content 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, Continuous | Mean |
| 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 | Nicotine belief measures will be assessed by participant self-report and comprised of four broad constructs (nicotine beliefs, NRT beliefs, e-cigarette beliefs, and RNC cigarette beliefs). Nicotine beliefs relate specifically to its addictive nature, nicotine as a cause of cancer, and the role of nicotine in the health harms and cancer caused by smoking. The product-specific constructs (i.e., NRT, e-cigarette, RNC cigarette) include items related to the addictiveness of the product and the perceived health risks of the product compared to regular cigarettes. Three 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) cigarettes 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 | Median | Standard Deviation | score on a scale | Day 35 |
|
12 Weeks
Overall, there is minimal risk for serious adverse reactions as a consequence of enrolling in this study. AEs will be collected, assessed, and reported as per the study protocol.
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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 | Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will receive normal nicotine content cigarettes, but will not view nicotine messaging until the final study session. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess on right arm | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore Throat | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valentina Goren, MRA Project Manager | University of Pennsylvania | 215-746-3602 | vsoup@pennmedicine.upenn.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 | Aug 13, 2025 | Sep 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
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This project will recruit current, daily, non-menthol cigarette smokers to a 35-day, randomized, factorial design protocol. After a 7-day period of smoking own preferred brand cigarettes, participants will be randomized to a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes.
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Participants are unblinded to the nicotine content of their cigarette, either normal nicotine content (NNC) cigarettes or reduced nicotine content (RNC) cigarettes. However, participants will not be aware of the messaging condition assignment, either Nicotine Corrective Messaging (NCM) or the Delayed Control Messaging.
| Cigarette Condition | Other | After completing a 7-day period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content (RNC) cigarettes or normal nicotine content (NNC) cigarettes. |
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| Day 35 |
| Carbon Monoxide (CO) | Carbon monoxide (CO; measured in parts per million [ppm]) is a measure of toxicant exposure. Two measures assess daily CO exposure (collected at the onset of each session) and CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette. | Day 35 |
| Number of Participants With Intention to Use Tobacco/Nicotine Products | Participants will provide subjective ratings for 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. | Day 35 |
| Tobacco Use | Description 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). | Day 35 |
| Subjective Cigarette Ratings | Participants will provide subjective ratings of the strength and satisfaction for cigarettes smoked at Day 35 using a 100 mm Visual Analogue Scale (VAS). Anchors are item-specific (strength: 0 = "very weak," 100 = "very strong"), with lower scores indicating less favorable ratings. | Day 35 |
| Day 35 |
| 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). | Day 35 |
| Not Interested |
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| Out of area |
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| PI decision |
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| Significant Non-Compliance |
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| Unable to adhere to study protocol |
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After completing a 7-day baseline period, participants will receive reduced nicotine content cigarettes, but will not view nicotine messaging until the final study session. |
| BG002 | Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes. |
| BG003 | Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Cigarettes per Day | Mean | Standard Deviation | cigarettes per day |
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| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes |
After completing a 7-day baseline period, participants will receive normal nicotine content cigarettes, but will not view nicotine messaging until the final study session. |
| OG001 | Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will receive reduced nicotine content cigarettes, but will not view nicotine messaging until the final study session. |
| OG002 | Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes. |
| OG003 | Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes. |
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| Secondary | Daily Cigarette Consumption | Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters. | Posted | Mean | Standard Deviation | cigarettes per day | Day 35 |
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| Secondary | Puff Duration | Total puff duration, the sum of all puff durations per cigarette, will be collected using a standardized video scoring procedure. Participants will be video recorded while smoking each lab cigarette in order to collect smoking topography data. | Posted | Mean | Standard Deviation | Seconds | Day 35 |
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| Secondary | Carbon Monoxide (CO) | Carbon monoxide (CO; measured in parts per million [ppm]) is a measure of toxicant exposure. Two measures assess daily CO exposure (collected at the onset of each session) and CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette. | Posted | Mean | Standard Deviation | Parts per million | Day 35 |
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| Secondary | Number of Participants With Intention to Use Tobacco/Nicotine Products | Participants will provide subjective ratings for 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. | Posted | Number | participants | Day 35 |
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| Secondary | Tobacco Use | Description 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). | Posted | Mean | Standard Deviation | Days | Day 35 |
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| Secondary | Subjective Cigarette Ratings | Participants will provide subjective ratings of the strength and satisfaction for cigarettes smoked at Day 35 using a 100 mm Visual Analogue Scale (VAS). Anchors are item-specific (strength: 0 = "very weak," 100 = "very strong"), with lower scores indicating less favorable ratings. | The analytic sample differs from the overall sample due to item non-response. | Posted | Mean | Standard Deviation | units on a scale | Day 35 |
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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 | Day 35 |
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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. | Posted | Mean | Standard Deviation | Score on a Likert Scale | Day 35 |
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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). | Posted | Mean | Standard Deviation | score on a scale | Day 35 |
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| 8 |
| 16 |
| 1 |
| 16 |
| 8 |
| 16 |
| EG001 | Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will receive reduced nicotine content cigarettes, but will not view nicotine messaging until the final study session. | 4 | 11 | 0 | 11 | 4 | 11 |
| EG002 | Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes. | 4 | 14 | 0 | 14 | 4 | 14 |
| EG003 | Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes. | 10 | 12 | 0 | 12 | 10 | 12 |
| Backache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Teeth Extraction | Surgical and medical procedures | Non-systematic Assessment |
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| UTI | Infections and infestations | Non-systematic Assessment |
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| Stress | Nervous system disorders | Non-systematic Assessment |
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| Nasal Congestion | General disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Chest Pain | Cardiac disorders | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Allergic Reaction | General disorders | Non-systematic Assessment |
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| Lightheadedness | General disorders | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Neck Pain, Shoulder Pain |
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| Anxiety | Nervous system disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Body Aches | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Burn | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| CO Boost |
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| Nicotine Replacement Product |
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| Low Nicotine Cigarette |
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| Cigarette |
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| Strength |
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| Most People |
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| Positive to Negative |
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| Good to Bad |
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