Clinical Trial of Smoking Cessation Mobile Phone Program
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|ClinicalTrials.gov Identifier: NCT02656745|
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Addiction Drug Addiction Drug Dependence Substance Use Disorder Tobacco Dependence||Device: Mobile Smoking Cessation Solution||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||416 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial of Mobile-Based Intervention for Smoking Cessation|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||June 2017|
Experimental: Mobile Smoking Cessation Solution
Subjects download & use the mobile application.
Device: 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.
- Number of Participants Who Remain Active Users of the Program [ Time Frame: 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.
- Number of Participants With Treatment-related Adverse Events [ Time Frame: 8 week core study ]To evaluate the tolerability and safety of the application
- Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] [ Time Frame: 8 week core study ]To assess whether continued user engagement is correlated with smoking cessation and behaviors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656745
|United States, New York|
|New York, New York, United States, 10013|
|Principal Investigator:||Nicholas Schork, PhD||J. Craig Venter Institute|
|Study Director:||Ted Silver||Click Therapeutics|