Trial Outcomes & Findings for Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness (NCT NCT03069482)

NCT ID: NCT03069482

Last Updated: 2020-11-10

Results Overview

Frequency of app openings in each group

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 63 participants
• Primary outcome timeframe: Daily throughout study duration, 4 months
• Results posted on: 2020-11-10

Participant Flow

Participant milestones

Measure	Learn to Quit A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Study STARTED	34	29
Overall Study COMPLETED	33	28
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Learn to Quit A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

Baseline characteristics by cohort

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	Total n=62 Participants Total of all reporting groups
Household Income <$35,000	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Household Income $35-50,0000	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Household Income $50-75,000	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Household Income $75-100,000	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Household Income >$100,000	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	48.4 years STANDARD_DEVIATION 11.2 • n=5 Participants	45.6 years STANDARD_DEVIATION 10.9 • n=7 Participants	47.1 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	29 participants n=7 Participants	62 participants n=5 Participants
CPD at Baseline	21 cigarettes per day STANDARD_DEVIATION 15.5 • n=5 Participants	14 cigarettes per day STANDARD_DEVIATION 6.4 • n=7 Participants	17.9 cigarettes per day STANDARD_DEVIATION 12.6 • n=5 Participants
MDD Diagnosis	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Bipolar Diagnosis	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Schizophrenia Spectrum Diagnosis	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Education Levels Secondary School or Less	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Education Levels Some College	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Education Levels Associate's Degree	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Education Levels Bachelor's Degree or Higher	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Disability Status	19 Participants n=5 Participants	9 Participants n=7 Participants	28 Participants n=5 Participants
Years of Smoking	25.6 years STANDARD_DEVIATION 12.9 • n=5 Participants	26.8 years STANDARD_DEVIATION 11.3 • n=7 Participants	26.2 years STANDARD_DEVIATION 12.1 • n=5 Participants
Nicotine Dependence	5.2 units on a scale STANDARD_DEVIATION 2.6 • n=5 Participants	4.7 units on a scale STANDARD_DEVIATION 2.3 • n=7 Participants	5.0 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants
Cognitive Functioning	-1 units on a scale n=5 Participants	-0.9 units on a scale n=7 Participants	-0.95 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Daily throughout study duration, 4 months

Frequency of app openings in each group

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Days of App Use	34.1 days Standard Deviation 27.7	32 days Standard Deviation 24.5

PRIMARY outcome

Timeframe: Daily throughout study duration, 4 months

Mean duration of app use in each group over the course of study participation (4 months)

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Duration of App Use	4.24 hours Standard Deviation 4.29	2.14 hours Standard Deviation 1.72

PRIMARY outcome

Timeframe: Approximately 15 months

Population: The number of participants analyzed in this sample is larger than the number of participants who were ultimately randomized to the study as reflected in the participant flow section. This sample includes all participants who were consented into the study regardless of their final eligibility status prior to randomization.

Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.

Outcome measures

Measure	Learn to Quit n=92 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Feasibility as Measured by Study Accrual Relative to Recruitment Goal	102 percentage of target accrual	—

PRIMARY outcome

Timeframe: 4-months

Number and percentage of subjects who complete 4-month follow up assessment

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Feasibility as Measured by Study Attrition	33 Participants	28 Participants

PRIMARY outcome

Timeframe: Approximately 15 months

Percent of subjects responding to ads and clinician referrals

Outcome measures

Measure	Learn to Quit n=499 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Recruitment Yield Effort	290 Participants	—

PRIMARY outcome

Timeframe: Approximately 19 months

Population: Number of total possible assessment measures that could have been completed in each group.

Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.

Outcome measures

Measure	Learn to Quit n=1617 assessments A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=1421 assessments A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Feasibility of Measurement Strategy	1353 assessments	1284 assessments

PRIMARY outcome

Timeframe: 1-month follow-up

10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Usability of App Design as Measured by the System Usability Scale (SUS)	87.3 score on a scale Standard Deviation 13.6	79.4 score on a scale Standard Deviation 15

PRIMARY outcome

Timeframe: 2-month follow-up

10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Usability of App Design as Measured by the System Usability Scale (SUS)	84.4 score on a scale Standard Deviation 13.5	75.6 score on a scale Standard Deviation 19.6

PRIMARY outcome

Timeframe: 3-month follow-up

10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Usability of App Design as Measured by the System Usability Scale (SUS)	83.2 score on a scale Standard Deviation 14.1	80.8 score on a scale Standard Deviation 15.6

PRIMARY outcome

Timeframe: 4-month follow-up

10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Usability of App Design as Measured by the System Usability Scale (SUS)	85.2 score on a scale Standard Deviation 13.9	78.7 score on a scale Standard Deviation 19.3

SECONDARY outcome

Timeframe: 1 month follow-up

Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed 7-day Point Prevalence Abstinence	3 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 month follow-up

Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed 7-day Point Prevalence Abstinence	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 month follow-up

Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed 7-day Point Prevalence Abstinence	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 month follow-up

Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed 7-day Point Prevalence Abstinence	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 month follow up

Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.

Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent

Outcome measures

Measure	Learn to Quit n=11 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=15 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed Prolonged Abstinence Rates	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 2 month follow up

Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.

Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent

Outcome measures

Measure	Learn to Quit n=5 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=6 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed Prolonged Abstinence Rates	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 month follow up

Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.

Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.

Outcome measures

Measure	Learn to Quit n=6 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=3 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed Prolonged Abstinence Rates	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 month follow up

Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.

Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.

Outcome measures

Measure	Learn to Quit n=3 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=4 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Biochemically Confirmed Prolonged Abstinence Rates	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month follow up

Participants who self-reported not smoking for 30 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
30-day Point Prevalence Abstinence Rates	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 month follow up

Participants who self-reported not smoking for 30 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
30-day Point Prevalence Abstinence Rates	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 month follow up

Participants who self-reported not smoking for 30 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
30-day Prevalence Abstinence Rates	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 month follow up

Participants who self-reported not smoking for 30 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
30-day Point Prevalence Abstinence Rates	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 month follow up

Participants who self-reported not smoking for 7 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
7-day Point Prevalence Abstinence	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 2 month follow up

Participants who self-reported not smoking for 7 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
7-day Point Prevalence Abstinence	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 month follow up

Participants who self-reported not smoking for 7 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
7-day Point Prevalence Abstinence	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 4 month follow up

Participants who self-reported not smoking for 7 days prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
7-day Point Prevalence Abstinence	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 month follow up

Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
24-hour Point Prevalence Abstinence	8 Participants	10 Participants

SECONDARY outcome

Timeframe: 2 month follow up

Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
24-hour Point Prevalence Abstinence	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 month follow up

Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
24-hour Point Prevalence Abstinence	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 4 month follow up

Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
24-hour Point Prevalence Abstinence	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 1 month follow up

Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Average Number of Quit Attempts Per Arm	1.16 quit attempts Standard Deviation 1.19	3.04 quit attempts Standard Deviation 2.29

SECONDARY outcome

Timeframe: 2 month follow up

Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Average Number of Quit Attempts Per Arm	1.44 quit attempts Standard Deviation 1.34	2.55 quit attempts Standard Deviation 1.82

SECONDARY outcome

Timeframe: 3 month follow up

Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Average Number of Quit Attempts Per Arm	1.83 quit attempts Standard Deviation 2.17	3.30 quit attempts Standard Deviation 3.61

SECONDARY outcome

Timeframe: 4 month follow up

Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Average Number of Quit Attempts Per Arm	1.61 quit attempts Standard Deviation 1.85	1.96 quit attempts Standard Deviation 1.90

SECONDARY outcome

Timeframe: Baseline to 1, 2, 3 and 4 month follow up

The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating "no dependence" and the highest score indicating "very dependent"

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence Week 4	0.81 units on a scale Standard Deviation 2.17	1.88 units on a scale Standard Deviation 2.90
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence Week 8	1 units on a scale Standard Deviation 1.97	1.47 units on a scale Standard Deviation 2.67
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence Week 12	1.29 units on a scale Standard Deviation 2.03	1.74 units on a scale Standard Deviation 2.40
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence Week 16	1.16 units on a scale Standard Deviation 2.03	1.35 units on a scale Standard Deviation 2.48

SECONDARY outcome

Timeframe: Baseline to 1, 2, 3 and 4 month follow up

Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Change in Average Number of Cigarettes Smoked Per Day Week 4	10.0 cigarettes per day Standard Deviation 9.9	5.2 cigarettes per day Standard Deviation 10.8
Change in Average Number of Cigarettes Smoked Per Day Week 8	11.3 cigarettes per day Standard Deviation 12.0	7.5 cigarettes per day Standard Deviation 7.6
Change in Average Number of Cigarettes Smoked Per Day Week 12	11.5 cigarettes per day Standard Deviation 12.3	6.0 cigarettes per day Standard Deviation 7.6
Change in Average Number of Cigarettes Smoked Per Day Week 16	12.3 cigarettes per day Standard Deviation 11.5	5.9 cigarettes per day Standard Deviation 5.9

SECONDARY outcome

Timeframe: 1 month follow up

Days of patch use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Patch Utilization	10.3 days of patch use Standard Deviation 10.4	13.9 days of patch use Standard Deviation 11.6

SECONDARY outcome

Timeframe: 2 month follow up

Days of patch use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Patch Utilization	11 days of patch use Standard Deviation 11.2	14.9 days of patch use Standard Deviation 12.8

SECONDARY outcome

Timeframe: 3 month follow up

Days of patch use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Patch Utilization	8.4 days of patch use Standard Deviation 10.7	7.4 days of patch use Standard Deviation 9.5

SECONDARY outcome

Timeframe: 4 month follow up

Days of patch use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Patch Utilization	3.4 days of patch use Standard Deviation 6.2	5.3 days of patch use Standard Deviation 8.6

SECONDARY outcome

Timeframe: 1 month follow up

Days of lozenge use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Lozenge Utilization	7.8 days of lozenge use Standard Deviation 9.7	10 days of lozenge use Standard Deviation 10

SECONDARY outcome

Timeframe: 2 month follow up

Days of lozenge use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Lozenge Utilization	5.1 days of lozenge use Standard Deviation 9.3	7 days of lozenge use Standard Deviation 10.4

SECONDARY outcome

Timeframe: 3 month follow up

Days of lozenge use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Lozenge Utilization	4.4 days of lozenge use Standard Deviation 8	4.1 days of lozenge use Standard Deviation 7.2

SECONDARY outcome

Timeframe: 4 month follow up

Days of lozenge use over the last 30 days.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Nicotine Replacement Lozenge Utilization	2.3 days of lozenge use Standard Deviation 6.3	1.3 days of lozenge use Standard Deviation 3.1

SECONDARY outcome

Timeframe: Daily throughout study duration, 4 months

Population: Participants in the Learn to Quit group.

Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Affect Ratings - Learn to Quit	5.4666165 score on a scale Standard Deviation 2.155668	—

SECONDARY outcome

Timeframe: Daily throughout study, 4 months

Population: Participants in the QuitGuide group.

Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day.

Outcome measures

Measure	Learn to Quit n=29 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Affect Ratings - QuitGuide Positive Affect	52.26 Percent of counts	—
Affect Ratings - QuitGuide Negative Affect	43.90 Percent of counts	—
Affect Ratings - QuitGuide Mixed Affect	3.83 Percent of counts	—

SECONDARY outcome

Timeframe: Daily throughout study duration, 4 months

Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Smoking Cravings	6.13 units on a scale Standard Deviation 2.25	4.55 units on a scale Standard Deviation 2.98

SECONDARY outcome

Timeframe: 1 month follow up

Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Psychotic Symptoms Positive symptoms	11.74 score on a scale Standard Deviation 3.43	11.85 score on a scale Standard Deviation 3.52
Psychotic Symptoms Negative symptoms	11.61 score on a scale Standard Deviation 4.38	10.81 score on a scale Standard Deviation 4.33

SECONDARY outcome

Timeframe: 2 month follow up

Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Psychotic Symptoms Positive symptoms	11.55 score on a scale Standard Deviation 3.49	10.79 score on a scale Standard Deviation 3.79
Psychotic Symptoms Negative symptoms	12.45 score on a scale Standard Deviation 4.42	11.38 score on a scale Standard Deviation 5.38

SECONDARY outcome

Timeframe: 3 month follow up

Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Psychotic Symptoms Positive symptoms	11.10 score on a scale Standard Deviation 4.21	12.32 score on a scale Standard Deviation 5.00
Psychotic Symptoms Negative symptoms	12.57 score on a scale Standard Deviation 5.82	12.25 score on a scale Standard Deviation 5.08

SECONDARY outcome

Timeframe: 4 month follow up

Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Psychotic Symptoms Positive symptoms	11.63 score on a scale Standard Deviation 4.53	11.55 score on a scale Standard Deviation 3.86
Psychotic Symptoms Negative symptoms	12.16 score on a scale Standard Deviation 4.25	12.23 score on a scale Standard Deviation 5.23

SECONDARY outcome

Timeframe: 1 month follow up

General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
General Psychiatric Symptoms	0.92 score on a scale Standard Deviation 0.59	0.84 score on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: 2 month follow up

General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
General Psychiatric Symptoms	0.87 score on a scale Standard Deviation 0.64	0.68 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 3 month follow up

General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
General Psychiatric Symptoms	0.80 score on a scale Standard Deviation 0.58	0.80 score on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: 4 month follow up

General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.

Outcome measures

Measure	Learn to Quit n=33 Participants A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 Participants A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
General Psychiatric Symptoms	0.94 score on a scale Standard Deviation 0.75	0.90 score on a scale Standard Deviation 0.64

Adverse Events

Learn to Quit

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

NCI QuitGuide

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Learn to Quit n=33 participants at risk A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 participants at risk A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Skin and subcutaneous tissue disorders Second degree burns	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Blood and lymphatic system disorders Low blood pressure	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Blood and lymphatic system disorders Hospitalization from elevated blood sugar	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Social circumstances Heroin overdose	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Social circumstances Withdrawal from methadone	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Surgical and medical procedures Knee surgery	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Surgical and medical procedures Hospitalized because of two broken arms	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Psychiatric disorders Hospitalization due to suicidal ideation	3.0% 1/33 • Number of events 2 • 16 weeks	0.00% 0/29 • 16 weeks
Nervous system disorders Mini-stroke (TIA)	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Respiratory, thoracic and mediastinal disorders Asthma attack	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Surgical and medical procedures Hernia repair surgery	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks

Other adverse events

Measure	Learn to Quit n=33 participants at risk A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.	NCI QuitGuide n=29 participants at risk A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Psychiatric disorders Anxiety and stress	12.1% 4/33 • Number of events 4 • 16 weeks	13.8% 4/29 • Number of events 4 • 16 weeks
Surgical and medical procedures Dental procedures	9.1% 3/33 • Number of events 3 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Body aches and pains	18.2% 6/33 • Number of events 7 • 16 weeks	20.7% 6/29 • Number of events 6 • 16 weeks
Vascular disorders Changes in blood pressure	9.1% 3/33 • Number of events 4 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Gastrointestinal disorders Burning in mouth/throat/chest	9.1% 3/33 • Number of events 3 • 16 weeks	20.7% 6/29 • Number of events 6 • 16 weeks
Musculoskeletal and connective tissue disorders Broken/sprained body parts	18.2% 6/33 • Number of events 6 • 16 weeks	6.9% 2/29 • Number of events 2 • 16 weeks
Respiratory, thoracic and mediastinal disorders Coughing	12.1% 4/33 • Number of events 5 • 16 weeks	13.8% 4/29 • Number of events 5 • 16 weeks
Infections and infestations Cold/flu	18.2% 6/33 • Number of events 7 • 16 weeks	17.2% 5/29 • Number of events 8 • 16 weeks
Gastrointestinal disorders Acid reflux	0.00% 0/33 • 16 weeks	10.3% 3/29 • Number of events 3 • 16 weeks
Respiratory, thoracic and mediastinal disorders Allergies/asthma	3.0% 1/33 • Number of events 1 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Gastrointestinal disorders Nausea	18.2% 6/33 • Number of events 7 • 16 weeks	13.8% 4/29 • Number of events 4 • 16 weeks
Skin and subcutaneous tissue disorders Itchy/irritated skin	18.2% 6/33 • Number of events 7 • 16 weeks	20.7% 6/29 • Number of events 6 • 16 weeks
Skin and subcutaneous tissue disorders Skin breakouts	6.1% 2/33 • Number of events 2 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Psychiatric disorders Suicidal ideation	9.1% 3/33 • Number of events 3 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Psychiatric disorders Nightmares/vivid dreams	3.0% 1/33 • Number of events 1 • 16 weeks	17.2% 5/29 • Number of events 5 • 16 weeks
Respiratory, thoracic and mediastinal disorders Hiccups	3.0% 1/33 • Number of events 1 • 16 weeks	6.9% 2/29 • Number of events 2 • 16 weeks
Psychiatric disorders Sleep issues	6.1% 2/33 • Number of events 2 • 16 weeks	6.9% 2/29 • Number of events 2 • 16 weeks
Psychiatric disorders Frustration due to phone/app issues	3.0% 1/33 • Number of events 1 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Infections and infestations Infections	0.00% 0/33 • 16 weeks	6.9% 2/29 • Number of events 2 • 16 weeks
Surgical and medical procedures Tumor removal (procedure)	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cyst/abcess removal	3.0% 1/33 • Number of events 1 • 16 weeks	6.9% 2/29 • Number of events 2 • 16 weeks
Social circumstances Accidents	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Gastrointestinal disorders Constipation	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Skin and subcutaneous tissue disorders Lacerations	3.0% 1/33 • Number of events 1 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Psychiatric disorders Agoraphobia	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Product Issues Aversion to NRT taste	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
General disorders Headaches	3.0% 1/33 • Number of events 1 • 16 weeks	6.9% 2/29 • Number of events 2 • 16 weeks
Surgical and medical procedures Eye procedure	3.0% 1/33 • Number of events 1 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Reproductive system and breast disorders Reproductive problems	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
General disorders Cancer	6.1% 2/33 • Number of events 2 • 16 weeks	0.00% 0/29 • 16 weeks
Psychiatric disorders Opioid withdrawal	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Eye disorders Vision problems	6.1% 2/33 • Number of events 2 • 16 weeks	0.00% 0/29 • 16 weeks
Respiratory, thoracic and mediastinal disorders Congestion	9.1% 3/33 • Number of events 3 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Product Issues Dry mouth while using lozenges	6.1% 2/33 • Number of events 2 • 16 weeks	0.00% 0/29 • 16 weeks
Psychiatric disorders Memory problems	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Congenital, familial and genetic disorders Changes in blood sugar levels	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Metabolism and nutrition disorders Thyroid problems	3.0% 1/33 • Number of events 1 • 16 weeks	0.00% 0/29 • 16 weeks
Infections and infestations Sore throat	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 1 • 16 weeks
Cardiac disorders Increased heart rate	0.00% 0/33 • 16 weeks	3.4% 1/29 • Number of events 2 • 16 weeks
Psychiatric disorders Changes in mood	3.0% 1/33 • Number of events 1 • 16 weeks	6.9% 2/29 • Number of events 2 • 16 weeks
Musculoskeletal and connective tissue disorders Tooth pain	6.1% 2/33 • Number of events 2 • 16 weeks	0.00% 0/29 • 16 weeks

Additional Information

Dr. Roger Vilardaga

Duke University Psychiatry & Behavioral Sciences

Phone: 9196813441

Email: roger.vilardaga@duke.edu

Results disclosure agreements

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