Clinical Trial of Smoking Cessation Mobile Phone Program
Condition: Nicotine Addiction; Drug Addiction; Drug Dependence; Substance Use Disorder; Tobacco Dependence
MeSH terms: Substance-Related Disorders; Tobacco Use Disorder; Behavior, Addictive
Study type: Interventional

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.
    

Intervention name(s): Mobile Smoking Cessation Solution
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking; Cigarette Smoking; Tobacco Smoking; Nicotine; Drug; Addiction; Tobacco