Trial Outcomes & Findings for Clinical Trial of Smoking Cessation Mobile Phone Program (NCT NCT02656745)

Last Updated: 2018-11-14

Results Overview

The primary objective is to assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8 week primary study period. Active use is defined as the manipulation of at least one component of the application per week.

Recruitment status

COMPLETED

Study phase

Target enrollment

416 participants

Primary outcome timeframe

8 week core study

Results posted on

2018-11-14

Participant Flow

We recruited potential participants from May to July 2016. Digital advertisements were posted to social media outlets targeting users who searched for "quit smoking". The study team contacted respondents by telephone to prescreen for eligibility and, if appropriate, directed them to a Web portal for the study.

All participants that completed informed consent, baseline survey, and downloaded the app were included in the single arm ITT sample.

Participant milestones

Participant milestones
Measure	Mobile Smoking Cessation Solution Subjects download \& use the mobile application. Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones \& engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program.
Overall Study STARTED	416
Overall Study COMPLETED	416
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of Smoking Cessation Mobile Phone Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mobile Smoking Cessation Solution n=416 Participants Subjects download \& use the mobile application. Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones \& engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program.
Age, Continuous	36 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	247 Participants n=5 Participants
Sex: Female, Male Male	169 Participants n=5 Participants
Race/Ethnicity, Customized White	315 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	37 Participants n=5 Participants
Race/Ethnicity, Customized African American	22 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	11 Participants n=5 Participants
Race/Ethnicity, Customized Native American	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	26 Participants n=5 Participants
Region of Enrollment United States	416 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 week core study

Population: 416 participants ultimately downloaded the app and constituted the ITT population.

Outcome measures

Outcome measures
Measure	Mobile Smoking Cessation Solution n=416 Participants Subjects download \& use the mobile application. Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones \& engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program.	Completers ITT sample- completed the outcome survey
Number of Participants Who Remain Active Users of the Program	365 Participants	—

SECONDARY outcome

Timeframe: 8 week core study

Population: 416 participants ultimately downloaded the app and constituted the ITT population.

To evaluate the tolerability and safety of the application

Outcome measures

Outcome measures
Measure	Mobile Smoking Cessation Solution n=416 Participants Subjects download \& use the mobile application. Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones \& engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program.	Completers ITT sample- completed the outcome survey
Number of Participants With Treatment-related Adverse Events	19 Participants	—

SECONDARY outcome

Timeframe: 8 week core study

Population: ITT sample included all subjects who consented to participation, fulfilled study entry criteria, completed the Introductory Questionnaire to receive the access code, and downloaded Clickotine®, and create a user profile. Completer sample included all ITT participants that also completed the outcome survey.

To assess whether continued user engagement is correlated with smoking cessation and behaviors.

Outcome measures

Outcome measures
Measure	Mobile Smoking Cessation Solution n=416 Participants Subjects download \& use the mobile application. Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones \& engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program.	Completers n=365 Participants ITT sample- completed the outcome survey
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] 30-day abstinence	109 Participants	109 Participants
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] 7-day abstinence	188 Participants	188 Participants

Adverse Events

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adverse Events n=416 participants at risk Total Adverse Events
Nervous system disorders Fatigue	0.72% 3/416 • Number of events 3 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Psychiatric disorders Mood Change	0.48% 2/416 • Number of events 2 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
General disorders Nightmare	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
General disorders Pharyngitis	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
General disorders Decreased Mobility	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Cardiac disorders Silent Myocardial Infarction	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Psychiatric disorders Stress	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Surgical and medical procedures Hand Repair Operation	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
General disorders Dental Discomfort	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Infections and infestations Kidney Infection	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Surgical and medical procedures Surgery	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
General disorders Nasopharyngitis	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
General disorders Emergency Care	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
General disorders Sciatica	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Nervous system disorders Migraine	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
Injury, poisoning and procedural complications Hernia Obstructive	0.24% 1/416 • Number of events 1 • 4 months Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.

Additional Information

Director of Scientific Affairs

Click Therapeutics

Phone: 646-844-2158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place