Trial Outcomes & Findings for Cessation in Non-Daily Smokers (NCT NCT02168855)

NCT ID: NCT02168855

Last Updated: 2020-05-06

Results Overview

Long term abstinence assessed and biochemically validated. The results reported are the number of participants self-reporting continuous abstinence throughout the 6-month, post-quit follow-up period. To be considered abstinent, a participant must have self-reported having not smoked during this period, demonstrated carbon monoxide levels less than or equal to 3 at each study visit, and cotinine values assessed via urinalysis at levels less than or equal to 25 ng/ml.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 505 participants
• Primary outcome timeframe: up to week 24
• Results posted on: 2020-05-06

Participant Flow

While 505 participants were enrolled in and began the study, only 369 of these were ultimately randomized to the active nicotine gum or inactive (placebo) gum arms. Those who were not randomized due to either participant-initiated drop out (n=36), research-team-initiated withdrawal due to noncompliance (n=83), or loss to followup (n=17).

Participant milestones

Measure	Active Nicotine Gum active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Overall Study STARTED	181	188
Overall Study COMPLETED	169	177
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cessation in Non-Daily Smokers

Baseline characteristics by cohort

Measure	Active Nicotine Gum n=181 Participants active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum n=188 Participants Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Total n=369 Participants Total of all reporting groups
Age, Continuous	42.72 years STANDARD_DEVIATION 13.76 • n=5 Participants	45.87 years STANDARD_DEVIATION 15.02 • n=7 Participants	44.32 years STANDARD_DEVIATION 14.48 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	102 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	86 Participants n=7 Participants	159 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	170 Participants n=5 Participants	179 Participants n=7 Participants	349 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	67 Participants n=5 Participants	81 Participants n=7 Participants	148 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	93 Participants n=7 Participants	187 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Cigarettes smoked per day on average, assessed over the last 28 days, including all days	1.8 cigarettes per day STANDARD_DEVIATION 1.5 • n=5 Participants	1.9 cigarettes per day STANDARD_DEVIATION 1.5 • n=7 Participants	1.9 cigarettes per day STANDARD_DEVIATION 1.5 • n=5 Participants
Cigarettes smoked per day on average, assessed over the last 28 days, including only smoking days	3.3 cigarettes per day STANDARD_DEVIATION 2.0 • n=5 Participants	3.9 cigarettes per day STANDARD_DEVIATION 2.9 • n=7 Participants	3.6 cigarettes per day STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: up to week 24

Long term abstinence assessed and biochemically validated. The results reported are the number of participants self-reporting continuous abstinence throughout the 6-month, post-quit follow-up period. To be considered abstinent, a participant must have self-reported having not smoked during this period, demonstrated carbon monoxide levels less than or equal to 3 at each study visit, and cotinine values assessed via urinalysis at levels less than or equal to 25 ng/ml.

Outcome measures

Measure	Active Nicotine Gum n=181 Participants active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum n=188 Participants Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Smoking Cessation, Continuous 6-month Abstinence	13 Participants	10 Participants

SECONDARY outcome

Timeframe: Six-week post-quit period

Population: This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis.

Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. This measure assessed the intensity of craving experienced by participants during their attempt to quit smoking, via self-report. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

The scale's range was 0-100, with higher values reflecting higher levels of self-reported craving (maximum score of 100), whereas a score of 0 indicates no craving. "Background" craving is defined as that experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

Outcome measures

Measure	Active Nicotine Gum n=130 Participants active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Characteristics of Quit and Relapse Process - Craving Background	16.68 score on a scale Standard Error 1.61	—
Characteristics of Quit and Relapse Process - Craving Temptations to smoke	57.09 score on a scale Standard Error 2.50	—

SECONDARY outcome

Timeframe: Six-week post-quit period

Population: This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis.

Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. This measure assesses the intensity of negative affect participants experienced during their attempt to quit smoking. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

The scale's range was 0-100, with higher values reflecting higher levels of self-reported negative affect (maximum score of 100), whereas a score of 0 would indicate no negative affect. 50 indicates the population mean with a standard deviation of 10. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

Outcome measures

Measure	Active Nicotine Gum n=130 Participants active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Characteristics of Quit and Relapse Process - Negative Affect Background	49.13 T-score Standard Error 0.63	—
Characteristics of Quit and Relapse Process - Negative Affect Temptations to smoke	51.96 T-score Standard Error 0.84	—

SECONDARY outcome

Timeframe: Six-week post-quit period

Population: This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis.

Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns.To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

This measure reports the percentage of instances during which participants were not exposed to physical cues to smoke, such as cigarettes, ashtrays, or lighters), when experiencing temptations to smoke compared to experiencing no temptations to smoke. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

Outcome measures

Measure	Active Nicotine Gum n=130 Participants active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Characteristics of Quit and Relapse Process - Saw No Smoking Cues Temptations to smoke	59.11 percentage of assessments	—
Characteristics of Quit and Relapse Process - Saw No Smoking Cues Background	83.64 percentage of assessments	—

SECONDARY outcome

Timeframe: Six-week post-quit period

Population: This is the subset of placebo arm ITS participants who had achieved initial abstinence. These participants all submitted at least one background and one temptation report. To ensure the results were not influenced by using active nicotine gum, only participants receiving inactive gum (containing no nicotine) are included in this analysis.

Ecological Momentary Assessment (EMA) methods will be used to study the craving, withdrawal, and relapse processes among ITS and relate relapse contexts to baseline smoking patterns. To ensure the results were not influenced by the use of active nicotine replacement gum, only the participants receiving inactive gum (containing no nicotine) are included in this analysis.

This measure reports the percentage of instances during which participants were not exposed to others smoking nearby, when experiencing temptations to smoke compared to experiencing no temptations to smoke. "Background" reports are defined as those experienced when a participant was not smoking or feeling a temptation to smoke. "Temptations to smoke" refers to situations where a participant was tempted to smoke and did, or tempted to and did not.

Outcome measures

Measure	Active Nicotine Gum n=130 Participants active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Characteristics of Quit and Relapse Process - No Others Smoking Nearby Temptations to smoke	66.82 percentage of assessments	—
Characteristics of Quit and Relapse Process - No Others Smoking Nearby Background	90.42 percentage of assessments	—

Adverse Events

Active Nicotine Gum

Serious events: 9 serious events

Other events: 93 other events

Deaths: 0 deaths

Inactive Gum

Serious events: 14 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Nicotine Gum n=181 participants at risk active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum n=188 participants at risk Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Gastrointestinal disorders Hospitalization for gastrointestinal viral infection	1.1% 2/181 • Number of events 2 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Respiratory, thoracic and mediastinal disorders Hospitalization for pneumonia	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	1.1% 2/188 • Number of events 2 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Surgical and medical procedures Foot surgery	0.55% 1/181 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Surgical and medical procedures Surgery for Appendicitis	0.55% 1/181 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Surgical and medical procedures Hemorrhoidectomy	0.55% 1/181 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Immune system disorders Hospitalization for lupus flare-up	0.55% 1/181 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Gastrointestinal disorders Hospitalization for GERD flare-up	0.55% 1/181 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Surgical and medical procedures Surgery on ovaries	0.55% 1/181 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Musculoskeletal and connective tissue disorders Worsening of degenerative disc disease	0.55% 1/181 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.00% 0/188 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Injury, poisoning and procedural complications Hospitalization for wrist injury	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Musculoskeletal and connective tissue disorders Carpal tunnel surgery	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	1.1% 2/188 • Number of events 2 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Surgical and medical procedures Root canal	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Injury, poisoning and procedural complications Hospitalization for after car accident	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Vascular disorders Hospitalization for high blood pressure	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Respiratory, thoracic and mediastinal disorders Worsening of lung disease	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Injury, poisoning and procedural complications Broken hip	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Reproductive system and breast disorders Breast cancer	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Skin and subcutaneous tissue disorders Hospitalization for allergic skin reaction	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Endocrine disorders Hospitalization for thyroid disorder	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Eye disorders Corneal implant surgery	0.00% 0/181 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	0.53% 1/188 • Number of events 1 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.

Other adverse events

Measure	Active Nicotine Gum n=181 participants at risk active nicotine gum: 2 mg, standard over-the-counter nicotine replacement therapy gum Standard behavioral therapy: Standard behavioral therapy for smoking cessation	Inactive Gum n=188 participants at risk Standard behavioral therapy: Standard behavioral therapy for smoking cessation
Gastrointestinal disorders Gastric upset	15.5% 28/181 • Number of events 28 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	6.9% 13/188 • Number of events 13 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Metabolism and nutrition disorders Weight gain	7.7% 14/181 • Number of events 14 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	8.0% 15/188 • Number of events 15 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
General disorders Headache	8.3% 15/181 • Number of events 15 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	6.9% 13/188 • Number of events 13 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 10/181 • Number of events 10 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	7.4% 14/188 • Number of events 14 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
General disorders Irritability	7.2% 13/181 • Number of events 13 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	3.7% 7/188 • Number of events 7 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.
General disorders Throat or mouth irritation	7.2% 13/181 • Number of events 13 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.	1.6% 3/188 • Number of events 3 • Data for adverse events was collected over the period of time during which each participant was enrolled and participating in the study. For participants completing the entire study, this period would be approximately 26 weeks - i.e., during the 2 weeks during which baseline data was collected, and the 24 weeks that began with their quit date and continued on for the following 6 months. Adverse events were assessed during study visits via in-session interactions in which study participants were prompted to describe their experiences since the prior visit in an open-ended format and answers were recorded by research assistants within study session tracking assessment forms.

Additional Information

Dr. Brian Primack

University of Arkansas

Phone: 479-575-3208

Email: bprimack@uark.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place