Clinical Trial of Smoking Cessation Mobile Phone Program
Clinical Trial of Mobile-Based Intervention for Smoking Cessation
1 other identifier
interventional
416
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
November 14, 2018
CompletedNovember 14, 2018
September 1, 2018
4 months
January 12, 2016
September 12, 2018
October 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 week core study
Secondary Outcomes (2)
Number of Participants With Treatment-related Adverse Events
8 week core study
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
8 week core study
Study Arms (1)
Mobile Smoking Cessation Solution
EXPERIMENTALSubjects download \& use the mobile application.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Click Therapeutics
New York, New York, 10013, United States
Related Publications (1)
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.
PMID: 28442453DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Scientific Affairs
- Organization
- Click Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas Schork, PhD
J. Craig Venter Institute
- STUDY DIRECTOR
Ted Silver
Click Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 15, 2016
Study Start
May 1, 2016
Primary Completion
September 1, 2016
Study Completion
June 1, 2017
Last Updated
November 14, 2018
Results First Posted
November 14, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share