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Completed

NCT Number: NCT02656745

Clinical Trial of Smoking Cessation Mobile Phone Program

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.

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Key information

Conditions

Nicotine Addiction Behavior Behavior, Addictive Chemically-Induced Disorders Cigarette Smoking Compulsive Behavior Drug Addiction Drug Dependence Impulsive Behavior Mental Disorders Smoking Substance Use Disorder Substance-Related Disorders Tobacco Dependence Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Click Therapeutics

New York, 10013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Smoking Cessation Solution

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants With Treatment-related Adverse Events

    Time frame: 8 week core study

    To evaluate the tolerability and safety of the application

  2. 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.

Sponsors and collaborators

Lead sponsor

Click Therapeutics, Inc.

Industry

Registry information

Official study title

Clinical Trial of Mobile-Based Intervention for Smoking Cessation

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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