Clinical Trial of Smoking Cessation Mobile Phone Program
Primary Purpose
Nicotine Addiction, Drug Addiction, Drug Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Smoking Cessation Solution
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Addiction focused on measuring Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
Eligibility Criteria
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
Sites / Locations
- Click Therapeutics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile Smoking Cessation Solution
Arm Description
Subjects download & use the mobile application.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Treatment-related Adverse Events
To evaluate the tolerability and safety of the application
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
To assess whether continued user engagement is correlated with smoking cessation and behaviors.
Full Information
NCT ID
NCT02656745
First Posted
January 12, 2016
Last Updated
October 16, 2018
Sponsor
Click Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02656745
Brief Title
Clinical Trial of Smoking Cessation Mobile Phone Program
Official Title
Clinical Trial of Mobile-Based Intervention for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence
Keywords
Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Smoking Cessation Solution
Arm Type
Experimental
Arm Description
Subjects download & use the mobile application.
Intervention Type
Device
Intervention Name(s)
Mobile Smoking Cessation Solution
Intervention Description
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 Measure Information:
Title
Number of Participants Who Remain Active Users of the Program
Description
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.
Time Frame
8 week core study
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events
Description
To evaluate the tolerability and safety of the application
Time Frame
8 week core study
Title
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
Description
To assess whether continued user engagement is correlated with smoking cessation and behaviors.
Time Frame
8 week core study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Schork, PhD
Organizational Affiliation
J. Craig Venter Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ted Silver
Organizational Affiliation
Click Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Click Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28442453
Citation
Iacoviello BM, Steinerman JR, Klein DB, Silver TL, Berger AG, Luo SX, Schork NJ. Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation. JMIR Mhealth Uhealth. 2017 Apr 25;5(4):e56. doi: 10.2196/mhealth.7226.
Results Reference
derived
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Clinical Trial of Smoking Cessation Mobile Phone Program
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