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Clinical Trial of Smoking Cessation Mobile Phone Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02656745
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
Click Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Nicotine Addiction Drug Addiction Drug Dependence Substance Use Disorder Tobacco Dependence Device: Mobile Smoking Cessation Solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02656745

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United States, New York
Click Therapeutics
New York, New York, United States, 10013
Sponsors and Collaborators
Click Therapeutics, Inc.
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Principal Investigator: Nicholas Schork, PhD J. Craig Venter Institute
Study Director: Ted Silver Click Therapeutics
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Click Therapeutics, Inc. Identifier: NCT02656745    
Other Study ID Numbers: 20152568
First Posted: January 15, 2016    Key Record Dates
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Click Therapeutics, Inc.:
Cigarette Smoking
Tobacco Smoking
Additional relevant MeSH terms:
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Substance-Related Disorders
Tobacco Use Disorder
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders