Clinical trial NCT02656745: Clinical Trial of Smoking Cessation Mobile Phone Program
Official title: Clinical Trial of Mobile-Based Intervention for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Addiction
Drug Addiction
Drug Dependence
Substance Use Disorder
Tobacco Dependence
Keywords: Smoking
Cigarette Smoking
Tobacco Smoking
Nicotine
Drug
Addiction
Tobacco
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Number of Participants Who Remain Active Users of the Program
timeFrame: 8 week core study
Secondary outcomes:
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: 8 week core study
measure: Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
timeFrame: 8 week core study
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: J. Craig Venter Institute
name: Nicholas Schork, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Click Therapeutics
name: Ted Silver
role: STUDY_DIRECTOR
References:
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.