Clinical Trial of Smoking Cessation Mobile Phone Program

Tobacco Dependence Clinical Trial

Official title:

Clinical Trial of Mobile-Based Intervention for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656745
• Other study ID #: 20152568
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2018
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: June 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Drug Addiction
• Drug Dependence
• Nicotine Addiction
• Substance Use Disorder
• Substance-Related Disorders
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Treatment-related Adverse Events	To evaluate the tolerability and safety of the application	8 week core study
Secondary	Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]	To assess whether continued user engagement is correlated with smoking cessation and behaviors.	8 week core study