Clinical Trial of Smoking Cessation Mobile Phone Program

October 16, 2018 updated by: Click Therapeutics, Inc.

Clinical Trial of Mobile-Based Intervention for Smoking Cessation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • Click Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 week core study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-related Adverse Events
Time Frame: 8 week core study
To evaluate the tolerability and safety of the application
8 week core study
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.
8 week core study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Click Therapeutics, Inc.

Investigators

  • Principal Investigator: Nicholas Schork, PhD, J. Craig Venter Institute
  • Study Director: Ted Silver, Click Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20152568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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