Clinical Trial of Smoking Cessation Mobile Phone Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial of Mobile-Based Intervention for Smoking Cessation

Conditions
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Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence

Intervention / Treatment
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* Device: Mobile Smoking Cessation Solution


Participation Criteria
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Eligibility Criteria
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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: Do you smoke at least 5 cigarettes a day? - must say YES Are you interested in quitting in the next 30 days? - must say YES Do you have access to an Apple iPhone with iOS 8 (or higher) capabilities and internet access? - must say YES Are you between 18-65 years old? - must say YES Do you currently live in the United States? - must say YES Are you currently using a mobile phone-based smoking cessation intervention? - must say NO Are you willing and able to receive SMS messages throughout the study? - must say YES

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Smoking Cessation Solution<br>Subjects download & use the mobile application. | Device: Mobile Smoking Cessation Solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 week core study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-related Adverse Events | To evaluate the tolerability and safety of the application | 8 week core study | 
| Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] | To assess whether continued user engagement is correlated with smoking cessation and behaviors. | 8 week core study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco