Cigarette Smoking, Smoking Behaviors
Conditions
Keywords
Smoking Behavior
Brief summary
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.
Detailed description
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.
Interventions
OTHERNicotine Messaging
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.
OTHERCigarette Condition
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.
Sponsors
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Rutgers University
Andrew Strasser
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months. * Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (\ 6 weeks). * Plan to live in the area for the duration of the study. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form. * Able to communicate fluently in English (i.e., speaking, writing, and reading).
Exclusion criteria
* Smoke menthol cigarettes greater than 20% of the time. * Smoke cigarettes of non-standard circumference (e.g., wides, slim, capri, etc.) * Use of any nicotine containing products other than cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate. * Attempt to quit smoking over the duration of the study period. * Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Session 1 (D0). * History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Attendance at alcoholics anonymous or narcotics anonymous meetings will not be considered medical treatment for the purposes of this protocol. * Current alcohol consumption that exceeds 25 standard drinks/week. * Women, including all individuals assigned as female at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. * Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician. * Color blindness. * Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician. * Lifetime history of schizophrenia, psychosis, and/or bipolar disorder. * Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate. Additional, general reasons for exclusion include: * Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician. * Any circumstance, medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study. * Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn at any point throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Beliefs | Day 35 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carbon Monoxide (CO) | Day 35 | 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. |
| Number of Participants With Intention to Use Tobacco/Nicotine Products | Day 35 | 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. |
| Tobacco Use | Day 35 | 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). |
| Subjective Cigarette Ratings | Day 35 | 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. |
| Daily Cigarette Consumption | Day 35 | Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters. |
| Puff Duration | Day 35 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Attitudes About Nicotine | Day 35 | 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). |
| Behavioral Control | Day 35 | One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident). |
| Nicotine Related Norms | Day 35 | 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. |
Countries
United States
Participant flow
Recruitment details
This study enrolled adults who currently smoke cigarettes daily from the Philadelphia, PA region. The last participant completed on June 20, 2024.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 19 |
| 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. | 17 |
| 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. | 20 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 | 3 | 6 |
| Overall Study | Not Interested | 1 | 1 | 0 | 1 |
| Overall Study | Out of area | 0 | 0 | 0 | 1 |
| Overall Study | PI decision | 1 | 0 | 0 | 0 |
| Overall Study | Significant Non-Compliance | 0 | 1 | 0 | 0 |
| Overall Study | Unable to adhere to study protocol | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes |
|---|---|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 12.6 | 45.9 years STANDARD_DEVIATION 11.9 | 49.6 years STANDARD_DEVIATION 14.1 | 51.2 years STANDARD_DEVIATION 12.4 | 49.8 years STANDARD_DEVIATION 12.2 |
| Cigarettes per Day | 13.9 cigarettes per day STANDARD_DEVIATION 6.4 | 12.6 cigarettes per day STANDARD_DEVIATION 4.6 | 14.7 cigarettes per day STANDARD_DEVIATION 6.3 | 13.0 cigarettes per day STANDARD_DEVIATION 6.5 | 15.0 cigarettes per day STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 15 Participants | 19 Participants | 16 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 4 Participants | 6 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 12 Participants | 12 Participants | 13 Participants | 15 Participants |
| Sex/Gender, Customized Sex: Female, Male Female | 24 Participants | 6 Participants | 6 Participants | 4 Participants | 8 Participants |
| Sex/Gender, Customized Sex: Female, Male Male | 49 Participants | 12 Participants | 13 Participants | 12 Participants | 12 Participants |
| Sex/Gender, Customized Sex: Female, Male Refused | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 16 | 4 / 11 | 4 / 14 | 10 / 12 |
| other Total, other adverse events | 8 / 16 | 4 / 11 | 4 / 14 | 10 / 12 |
| serious Total, serious adverse events | 1 / 16 | 0 / 11 | 0 / 14 | 0 / 12 |
Outcome results
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.
Time frame: Day 35
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | Nicotine False Beliefs (range 3-11) | 7.5 score on a scale | Standard Deviation 2.6 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | NRT False Beliefs (range 4-20) | 10.8 score on a scale | Standard Deviation 1.8 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | E-Cigarette False Beliefs (range 2-14) | 9.6 score on a scale | Standard Deviation 2.3 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | Reduced Nicotine Content Cigarette False Beliefs (range 14-45) | 31.3 score on a scale | Standard Deviation 6 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | NRT False Beliefs (range 4-20) | 10.1 score on a scale | Standard Deviation 3.1 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | E-Cigarette False Beliefs (range 2-14) | 9.4 score on a scale | Standard Deviation 2.5 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | Reduced Nicotine Content Cigarette False Beliefs (range 14-45) | 31.6 score on a scale | Standard Deviation 5 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | Nicotine False Beliefs (range 3-11) | 8.1 score on a scale | Standard Deviation 2.4 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | E-Cigarette False Beliefs (range 2-14) | 8.3 score on a scale | Standard Deviation 2.8 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | NRT False Beliefs (range 4-20) | 10.3 score on a scale | Standard Deviation 2.8 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | Reduced Nicotine Content Cigarette False Beliefs (range 14-45) | 26.6 score on a scale | Standard Deviation 7.2 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Nicotine Beliefs | Nicotine False Beliefs (range 3-11) | 5.3 score on a scale | Standard Deviation 1.9 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | Reduced Nicotine Content Cigarette False Beliefs (range 14-45) | 24.2 score on a scale | Standard Deviation 5.5 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | NRT False Beliefs (range 4-20) | 8.7 score on a scale | Standard Deviation 1.5 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | Nicotine False Beliefs (range 3-11) | 4.8 score on a scale | Standard Deviation 2.2 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Nicotine Beliefs | E-Cigarette False Beliefs (range 2-14) | 8.2 score on a scale | Standard Deviation 2.4 |
p-value: 0.0008ANOVA
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.
Time frame: Day 35
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Carbon Monoxide (CO) | Daily CO Exposure | 14.9 Parts per million | Standard Deviation 7 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Carbon Monoxide (CO) | CO Boost | 5.6 Parts per million | Standard Deviation 4 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Carbon Monoxide (CO) | CO Boost | 4.3 Parts per million | Standard Deviation 2.5 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Carbon Monoxide (CO) | Daily CO Exposure | 12.4 Parts per million | Standard Deviation 6 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Carbon Monoxide (CO) | Daily CO Exposure | 15.6 Parts per million | Standard Deviation 11 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Carbon Monoxide (CO) | CO Boost | 5.1 Parts per million | Standard Deviation 3.1 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Carbon Monoxide (CO) | Daily CO Exposure | 15.8 Parts per million | Standard Deviation 9.9 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Carbon Monoxide (CO) | CO Boost | 6.4 Parts per million | Standard Deviation 2.2 |
p-value: 0.4208ANOVA
Secondary
Daily Cigarette Consumption
Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters.
Time frame: Day 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Daily Cigarette Consumption | 13.1 cigarettes per day | Standard Deviation 4.6 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Daily Cigarette Consumption | 12.5 cigarettes per day | Standard Deviation 6.2 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Daily Cigarette Consumption | 13.4 cigarettes per day | Standard Deviation 6.7 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Daily Cigarette Consumption | 13.5 cigarettes per day | Standard Deviation 6.7 |
p-value: 0.9804ANOVA
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.
Time frame: Day 35
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | E-Cigarette/Vape | 3 participants |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Nicotine Replacement Product | 4 participants |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Low Nicotine Cigarette | 8 participants |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Cigarette | 16 participants |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Nicotine Replacement Product | 2 participants |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Low Nicotine Cigarette | 2 participants |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Cigarette | 11 participants |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | E-Cigarette/Vape | 1 participants |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Low Nicotine Cigarette | 4 participants |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Nicotine Replacement Product | 3 participants |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Cigarette | 14 participants |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | E-Cigarette/Vape | 5 participants |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Cigarette | 11 participants |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Nicotine Replacement Product | 5 participants |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | E-Cigarette/Vape | 1 participants |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Number of Participants With Intention to Use Tobacco/Nicotine Products | Low Nicotine Cigarette | 5 participants |
p-value: 0.245Chi-squared
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.
Time frame: Day 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Puff Duration | 18.3 Seconds | Standard Deviation 6.3 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Puff Duration | 21.5 Seconds | Standard Deviation 12 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Puff Duration | 17.3 Seconds | Standard Deviation 7.9 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Puff Duration | 18.4 Seconds | Standard Deviation 7.9 |
p-value: 0.6579ANOVA
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.
Time frame: Day 35
Population: The analytic sample differs from the overall sample due to item non-response.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Subjective Cigarette Ratings | Satisfaction | 61.5 units on a scale | Standard Deviation 22.6 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Subjective Cigarette Ratings | Strength | 61.6 units on a scale | Standard Deviation 21.2 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Subjective Cigarette Ratings | Strength | 53.2 units on a scale | Standard Deviation 28.4 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Subjective Cigarette Ratings | Satisfaction | 36.4 units on a scale | Standard Deviation 30.6 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Subjective Cigarette Ratings | Satisfaction | 55.1 units on a scale | Standard Deviation 27 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Subjective Cigarette Ratings | Strength | 61.7 units on a scale | Standard Deviation 24.5 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Subjective Cigarette Ratings | Satisfaction | 36.3 units on a scale | Standard Deviation 22.1 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Subjective Cigarette Ratings | Strength | 36.6 units on a scale | Standard Deviation 27.3 |
p-value: 0.0235ANOVA
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).
Time frame: Day 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Tobacco Use | 30.1 Days | Standard Deviation 0.9 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Tobacco Use | 29.2 Days | Standard Deviation 4.9 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Tobacco Use | 28.4 Days | Standard Deviation 6.1 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Tobacco Use | 29.9 Days | Standard Deviation 0.3 |
p-value: 0.6396ANOVA
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).
Time frame: Day 35
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Attitudes About Nicotine | Safe to Dangerous | 4.2 score on a scale | Standard Deviation 0.9 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Attitudes About Nicotine | Good to Bad | 4.3 score on a scale | Standard Deviation 0.8 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Attitudes About Nicotine | Positive to Negative | 4.1 score on a scale | Standard Deviation 0.9 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Attitudes About Nicotine | Safe to Dangerous | 4.1 score on a scale | Standard Deviation 1.3 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Attitudes About Nicotine | Good to Bad | 4.5 score on a scale | Standard Deviation 0.8 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Attitudes About Nicotine | Positive to Negative | 4.3 score on a scale | Standard Deviation 0.9 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Attitudes About Nicotine | Positive to Negative | 4.1 score on a scale | Standard Deviation 1 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Attitudes About Nicotine | Safe to Dangerous | 3.6 score on a scale | Standard Deviation 1.2 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Attitudes About Nicotine | Good to Bad | 4.2 score on a scale | Standard Deviation 0.9 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Attitudes About Nicotine | Safe to Dangerous | 3.6 score on a scale | Standard Deviation 1.2 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Attitudes About Nicotine | Good to Bad | 3.7 score on a scale | Standard Deviation 1 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Attitudes About Nicotine | Positive to Negative | 4.0 score on a scale | Standard Deviation 1 |
p-value: 0.2304ANOVA
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).
Time frame: Day 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Behavioral Control | 2.4 Score on a Scale | Standard Deviation 1.2 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Behavioral Control | 1.7 Score on a Scale | Standard Deviation 0.9 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Behavioral Control | 2.3 Score on a Scale | Standard Deviation 1.3 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Behavioral Control | 2.5 Score on a Scale | Standard Deviation 1.1 |
p-value: 0.3564ANOVA
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.
Time frame: Day 35
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Nicotine Related Norms | Most People | 2.3 Score on a Likert Scale | Standard Deviation 1 |
| Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes | Nicotine Related Norms | People who are important to you | 2.4 Score on a Likert Scale | Standard Deviation 1 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Nicotine Related Norms | People who are important to you | 2.3 Score on a Likert Scale | Standard Deviation 1.1 |
| Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes | Nicotine Related Norms | Most People | 2.3 Score on a Likert Scale | Standard Deviation 0.8 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Nicotine Related Norms | Most People | 2.5 Score on a Likert Scale | Standard Deviation 1.1 |
| Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes | Nicotine Related Norms | People who are important to you | 2.5 Score on a Likert Scale | Standard Deviation 0.9 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Nicotine Related Norms | Most People | 2.0 Score on a Likert Scale | Standard Deviation 0.7 |
| Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes | Nicotine Related Norms | People who are important to you | 2.5 Score on a Likert Scale | Standard Deviation 0.8 |
p-value: 0.6057ANOVA