Trial Outcomes & Findings for Impact of Nicotine Messaging on Beliefs and Behavior (NCT NCT05108649)

Last Updated: 2025-12-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

Day 35

Results posted on

2025-12-08

Participant Flow

This study enrolled adults who currently smoke cigarettes daily from the Philadelphia, PA region. The last participant completed on June 20, 2024.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	18	19	17	20
Overall Study COMPLETED	16	11	14	12
Overall Study NOT COMPLETED	2	8	3	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.
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

Impact of Nicotine Messaging on Beliefs and Behavior

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes n=18 Participants 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.	Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=19 Participants 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.	Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=17 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=20 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Total n=74 Participants Total of all reporting groups
Age, Continuous	45.9 years STANDARD_DEVIATION 11.9 • n=37 Participants	49.6 years STANDARD_DEVIATION 14.1 • n=37 Participants	51.2 years STANDARD_DEVIATION 12.4 • n=74 Participants	49.8 years STANDARD_DEVIATION 12.2 • n=175 Participants	49.1 years STANDARD_DEVIATION 12.6 • n=700 Participants
Sex/Gender, Customized Sex: Female, Male · Female	6 Participants n=37 Participants	6 Participants n=37 Participants	4 Participants n=74 Participants	8 Participants n=175 Participants	24 Participants n=700 Participants
Sex/Gender, Customized Sex: Female, Male · Male	12 Participants n=37 Participants	13 Participants n=37 Participants	12 Participants n=74 Participants	12 Participants n=175 Participants	49 Participants n=700 Participants
Sex/Gender, Customized Sex: Female, Male · Refused	0 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants	0 Participants n=175 Participants	1 Participants n=700 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants	3 Participants n=175 Participants	6 Participants n=700 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=37 Participants	19 Participants n=37 Participants	16 Participants n=74 Participants	17 Participants n=175 Participants	67 Participants n=700 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=175 Participants	1 Participants n=700 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Race (NIH/OMB) Asian	1 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=175 Participants	1 Participants n=700 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Race (NIH/OMB) Black or African American	4 Participants n=37 Participants	6 Participants n=37 Participants	4 Participants n=74 Participants	4 Participants n=175 Participants	18 Participants n=700 Participants
Race (NIH/OMB) White	12 Participants n=37 Participants	12 Participants n=37 Participants	13 Participants n=74 Participants	15 Participants n=175 Participants	52 Participants n=700 Participants
Race (NIH/OMB) More than one race	1 Participants n=37 Participants	1 Participants n=37 Participants	0 Participants n=74 Participants	1 Participants n=175 Participants	3 Participants n=700 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=175 Participants	0 Participants n=700 Participants
Cigarettes per Day	12.6 cigarettes per day STANDARD_DEVIATION 4.6 • n=37 Participants	14.7 cigarettes per day STANDARD_DEVIATION 6.3 • n=37 Participants	13.0 cigarettes per day STANDARD_DEVIATION 6.5 • n=74 Participants	15.0 cigarettes per day STANDARD_DEVIATION 8.0 • n=175 Participants	13.9 cigarettes per day STANDARD_DEVIATION 6.4 • n=700 Participants

PRIMARY outcome

Timeframe: Day 35

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Nicotine Beliefs Nicotine False Beliefs (range 3-11)	5.3 score on a scale Standard Deviation 1.9	4.8 score on a scale Standard Deviation 2.2	7.5 score on a scale Standard Deviation 2.6	8.1 score on a scale Standard Deviation 2.4
Nicotine Beliefs NRT False Beliefs (range 4-20)	10.3 score on a scale Standard Deviation 2.8	8.7 score on a scale Standard Deviation 1.5	10.8 score on a scale Standard Deviation 1.8	10.1 score on a scale Standard Deviation 3.1
Nicotine Beliefs E-Cigarette False Beliefs (range 2-14)	8.3 score on a scale Standard Deviation 2.8	8.2 score on a scale Standard Deviation 2.4	9.6 score on a scale Standard Deviation 2.3	9.4 score on a scale Standard Deviation 2.5
Nicotine Beliefs Reduced Nicotine Content Cigarette False Beliefs (range 14-45)	26.6 score on a scale Standard Deviation 7.2	24.2 score on a scale Standard Deviation 5.5	31.3 score on a scale Standard Deviation 6.0	31.6 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Day 35

Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters.

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Daily Cigarette Consumption	13.4 cigarettes per day Standard Deviation 6.7	13.5 cigarettes per day Standard Deviation 6.7	13.1 cigarettes per day Standard Deviation 4.6	12.5 cigarettes per day Standard Deviation 6.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Puff Duration	17.3 Seconds Standard Deviation 7.9	18.4 Seconds Standard Deviation 7.9	18.3 Seconds Standard Deviation 6.3	21.5 Seconds Standard Deviation 12.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Carbon Monoxide (CO) CO Boost	5.1 Parts per million Standard Deviation 3.1	6.4 Parts per million Standard Deviation 2.2	5.6 Parts per million Standard Deviation 4.0	4.3 Parts per million Standard Deviation 2.5
Carbon Monoxide (CO) Daily CO Exposure	15.6 Parts per million Standard Deviation 11.0	15.8 Parts per million Standard Deviation 9.9	14.9 Parts per million Standard Deviation 7.0	12.4 Parts per million Standard Deviation 6.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Number of Participants With Intention to Use Tobacco/Nicotine Products E-Cigarette/Vape	5 participants	1 participants	3 participants	1 participants
Number of Participants With Intention to Use Tobacco/Nicotine Products Nicotine Replacement Product	3 participants	5 participants	4 participants	2 participants
Number of Participants With Intention to Use Tobacco/Nicotine Products Low Nicotine Cigarette	4 participants	5 participants	8 participants	2 participants
Number of Participants With Intention to Use Tobacco/Nicotine Products Cigarette	14 participants	11 participants	16 participants	11 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Tobacco Use	28.4 Days Standard Deviation 6.1	29.9 Days Standard Deviation 0.3	30.1 Days Standard Deviation 0.9	29.2 Days Standard Deviation 4.9

SECONDARY outcome

Timeframe: Day 35

Population: The analytic sample differs from the overall sample due to item non-response.

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.

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Subjective Cigarette Ratings Satisfaction	55.1 units on a scale Standard Deviation 27.0	36.3 units on a scale Standard Deviation 22.1	61.5 units on a scale Standard Deviation 22.6	36.4 units on a scale Standard Deviation 30.6
Subjective Cigarette Ratings Strength	61.7 units on a scale Standard Deviation 24.5	36.6 units on a scale Standard Deviation 27.3	61.6 units on a scale Standard Deviation 21.2	53.2 units on a scale Standard Deviation 28.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 35

One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident).

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Behavioral Control	2.3 Score on a Scale Standard Deviation 1.3	2.5 Score on a Scale Standard Deviation 1.1	2.4 Score on a Scale Standard Deviation 1.2	1.7 Score on a Scale Standard Deviation 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Nicotine Related Norms People who are important to you	2.5 Score on a Likert Scale Standard Deviation 0.9	2.5 Score on a Likert Scale Standard Deviation 0.8	2.4 Score on a Likert Scale Standard Deviation 1.0	2.3 Score on a Likert Scale Standard Deviation 1.1
Nicotine Related Norms Most People	2.5 Score on a Likert Scale Standard Deviation 1.1	2.0 Score on a Likert Scale Standard Deviation 0.7	2.3 Score on a Likert Scale Standard Deviation 1.0	2.3 Score on a Likert Scale Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 Participants After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.	Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 Participants 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.	Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 Participants 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.
Attitudes About Nicotine Safe to Dangerous	3.6 score on a scale Standard Deviation 1.2	3.6 score on a scale Standard Deviation 1.2	4.2 score on a scale Standard Deviation 0.9	4.1 score on a scale Standard Deviation 1.3
Attitudes About Nicotine Positive to Negative	4.1 score on a scale Standard Deviation 1.0	4.0 score on a scale Standard Deviation 1.0	4.1 score on a scale Standard Deviation 0.9	4.3 score on a scale Standard Deviation 0.9
Attitudes About Nicotine Good to Bad	4.2 score on a scale Standard Deviation 0.9	3.7 score on a scale Standard Deviation 1.0	4.3 score on a scale Standard Deviation 0.8	4.5 score on a scale Standard Deviation 0.8

Adverse Events

Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes

Serious events: 1 serious events

Other events: 8 other events

Deaths: 8 deaths

Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes

Serious events: 0 serious events

Other events: 10 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 participants at risk 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.	Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 participants at risk 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.	Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 participants at risk After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 participants at risk After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.
Infections and infestations Abscess on right arm	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	0.00% 0/12 • 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.

Other adverse events

Additional Information

Valentina Goren, MRA Project Manager

University of Pennsylvania

Phone: 215-746-3602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control: Delayed Control Messaging + Normal Nicotine Content Cigarettes n=16 participants at risk 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.	Experimental: Delayed Control Messaging + Reduced Nicotine Content Cigarettes n=11 participants at risk 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.	Experimental: Nicotine Corrective Messaging + Normal Nicotine Content Cigarettes n=14 participants at risk After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive normal nicotine content cigarettes.	Experimental: Nicotine Corrective Messaging + Reduced Nicotine Content Cigarettes n=12 participants at risk After completing a 7-day baseline period, participants will view nicotine corrective messaging at each in-person session and receive reduced nicotine content cigarettes.
Infections and infestations UTI	0.00% 0/16 • 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.	0.00% 0/11 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/12 • 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.
Nervous system disorders Stress	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	0.00% 0/12 • 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.
Surgical and medical procedures Teeth Extraction	0.00% 0/16 • 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.	0.00% 0/11 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/12 • 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.
Musculoskeletal and connective tissue disorders Backache	0.00% 0/16 • 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.	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/14 • 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.	0.00% 0/12 • 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.
General disorders Sore Throat	0.00% 0/16 • 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.	9.1% 1/11 • Number of events 1 • 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.	7.1% 1/14 • Number of events 1 • 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.	8.3% 1/12 • Number of events 1 • 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.
General disorders Nasal Congestion	12.5% 2/16 • Number of events 2 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	16.7% 2/12 • Number of events 2 • 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.
General disorders Nausea	12.5% 2/16 • Number of events 2 • 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.	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/14 • 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.	16.7% 2/12 • Number of events 2 • 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.
Cardiac disorders Chest Pain	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	0.00% 0/12 • 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	0.00% 0/12 • 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.
General disorders Allergic Reaction	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	8.3% 1/12 • Number of events 1 • 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.
General disorders Lightheadedness	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	8.3% 1/12 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	16.7% 2/12 • Number of events 2 • 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.
Nervous system disorders Anxiety	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	8.3% 1/12 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	16.7% 2/12 • Number of events 2 • 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.
General disorders Body Aches	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	8.3% 1/12 • Number of events 1 • 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.
General disorders Fatigue	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	8.3% 1/12 • Number of events 1 • 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.
Gastrointestinal disorders Diarrhea	0.00% 0/16 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	16.7% 2/12 • Number of events 2 • 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.
General disorders Fever	6.2% 1/16 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/14 • 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.	0.00% 0/12 • 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.
Skin and subcutaneous tissue disorders Burn	0.00% 0/16 • 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.	0.00% 0/11 • 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.	7.1% 1/14 • Number of events 1 • 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.	0.00% 0/12 • 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.
General disorders Headache	0.00% 0/16 • 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.	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/14 • 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.	0.00% 0/12 • 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.