Drug Addiction, Drug Dependence, Nicotine Addiction, Substance Use Disorder, Tobacco Dependence
Conditions
Keywords
Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
Brief summary
The Sponsor is doing a research study to assess the effects of a smartphone program designed to help users smoke less and eventually quit. When participants join, their involvement in the core study will last 8 weeks. After 8 weeks, they will have the option to continue using the program to guide their quit journey or participate in follow-up research.
Detailed description
The overarching study aim is to recruit and enroll a population of current smokers who are motivated to quit with the assistance of a mobile solution. The core study period will consist of 8 weeks of iPhone program usage. Comprehensive questionnaires will be given to the user during the course of their application usage. Users will receive notifications to link them to these online surveys, which will record their responses in a secure database. Following the 8-week core study, participants may continue usage of the program. During the course of their use of the program, participants will be asked to provide information regarding three general areas on a regular basis as part of their use of the app: smoking status, adherence to self or physician-directed quit plans (including but not limited to medications for smoking cessation and over-the-counter quit aids), and overall user satisfaction. One way that the program assesses these areas involves asking users to answer questions addressing whether or not the user used nicotine in the last 24 hours. At the end of each week, users will also be asked to report their cigarette count for each of the past 7 days, using the standardized reporting technique called the Timeline Followback (TLFB) Method Assessment (Sobell, 1992). At the 16-week mark and at the 24-week mark after enrollment, users will receive a brief questionnaire retrospectively looking at their cigarette usage, adherence to quit aids, and physical symptoms of nicotine withdrawal.
Interventions
DEVICEMobile 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.
Sponsors
Click Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 65 * Smokes at least 5 cigarettes daily * Is interested in quitting in the next 30 days * Owns an iPhone with iOS 8 or higher capabilities * Willing and able to receive SMS text messages * Able to comprehend the English-language and the informed consent form * Lives in the United States * Provides informed consent to participate in the study * Able and willing to comply with study procedures as outlined in the protocol and informed consent form
Exclusion criteria
* Unable or unwilling to provide informed consent * Responds appropriately to any item in the Eligibility Questionnaire: 1. Do you smoke at least 5 cigarettes a day? - must say YES 2. Are you interested in quitting in the next 30 days? - must say YES 3. Do you have access to an Apple iPhone with iOS 8 (or higher) capabilities and internet access? - must say YES 4. Are you between 18-65 years old? - must say YES 5. Do you currently live in the United States? - must say YES 6. Are you currently using a mobile phone-based smoking cessation intervention? - must say NO 7. Are you willing and able to receive SMS messages throughout the study? - must say YES
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Remain Active Users of the Program | 8 week core study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | 8 week core study | To evaluate the tolerability and safety of the application |
| Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] | 8 week core study | To assess whether continued user engagement is correlated with smoking cessation and behaviors. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All participants that completed informed consent, baseline survey, and downloaded the app were included in the single arm ITT sample.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 416 |
| Total | 416 |
Baseline characteristics
| Characteristic | Mobile Smoking Cessation Solution |
|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 10.8 |
| Race/Ethnicity, Customized African American | 22 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 37 Participants |
| Race/Ethnicity, Customized Native American | 5 Participants |
| Race/Ethnicity, Customized Other | 26 Participants |
| Race/Ethnicity, Customized White | 315 Participants |
| Region of Enrollment United States | 416 participants |
| Sex: Female, Male Female | 247 Participants |
| Sex: Female, Male Male | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 416 |
| other Total, other adverse events | 19 / 416 |
| serious Total, serious adverse events | 0 / 416 |
Outcome results
Primary
Number of Participants Who Remain Active Users of the Program
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.
Time frame: 8 week core study
Population: 416 participants ultimately downloaded the app and constituted the ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobile Smoking Cessation Solution | Number of Participants Who Remain Active Users of the Program | 365 Participants |
Secondary
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
To assess whether continued user engagement is correlated with smoking cessation and behaviors.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mobile Smoking Cessation Solution | Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] | 7-day abstinence | 188 Participants |
| Mobile Smoking Cessation Solution | Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] | 30-day abstinence | 109 Participants |
| Completers | Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] | 7-day abstinence | 188 Participants |
| Completers | Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] | 30-day abstinence | 109 Participants |
Secondary
Number of Participants With Treatment-related Adverse Events
To evaluate the tolerability and safety of the application
Time frame: 8 week core study
Population: 416 participants ultimately downloaded the app and constituted the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mobile Smoking Cessation Solution | Number of Participants With Treatment-related Adverse Events | 19 Participants |