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Trial record 83 of 2033 for:    Smoking Cessation

Clinical Trial of Smoking Cessation Mobile Phone Program

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ClinicalTrials.gov Identifier: NCT02656745
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Click Therapeutics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Nicotine Addiction
Drug Addiction
Drug Dependence
Substance Use Disorder
Tobacco Dependence
Intervention Device: Mobile Smoking Cessation Solution
Enrollment 416
Recruitment Details We recruited potential participants from May to July 2016. Digital advertisements were posted to social media outlets targeting users who searched for “quit smoking”. The study team contacted respondents by telephone to prescreen for eligibility and, if appropriate, directed them to a Web portal for the study.
Pre-assignment Details All participants that completed informed consent, baseline survey, and downloaded the app were included in the single arm ITT sample.
Arm/Group Title Mobile Smoking Cessation Solution
Hide Arm/Group Description

Subjects download & use the mobile application.

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.

Period Title: Overall Study
Started 416
Completed 416
Not Completed 0
Arm/Group Title Mobile Smoking Cessation Solution
Hide Arm/Group Description

Subjects download & use the mobile application.

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.

Overall Number of Baseline Participants 416
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 416 participants
36  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants
Female 247
Male 169
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants
White
315
  75.7%
Hispanic
37
   8.9%
African American
22
   5.3%
Asian or Pacific Islander
11
   2.6%
Native American
5
   1.2%
Other
26
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 416 participants
416
1.Primary Outcome
Title Number of Participants Who Remain Active Users of the Program
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
416 participants ultimately downloaded the app and constituted the ITT population.
Arm/Group Title Mobile Smoking Cessation Solution
Hide Arm/Group Description:

Subjects download & use the mobile application.

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.

Overall Number of Participants Analyzed 416
Measure Type: Count of Participants
Unit of Measure: Participants
365
  87.7%
2.Secondary Outcome
Title Number of Participants With Treatment-related Adverse Events
Hide Description To evaluate the tolerability and safety of the application
Time Frame 8 week core study
Hide Outcome Measure Data
Hide Analysis Population Description
416 participants ultimately downloaded the app and constituted the ITT population.
Arm/Group Title Adverse Events
Hide Arm/Group Description:
Total Adverse Events
Overall Number of Participants Analyzed 416
Measure Type: Number
Unit of Measure: Participants
19
3.Secondary Outcome
Title Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
Hide Description To assess whether continued user engagement is correlated with smoking cessation and behaviors.
Time Frame 8 week core study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT sample included all subjects who consented to participation, fulfilled study entry criteria, completed the Introductory Questionnaire to receive the access code, and downloaded Clickotine®, and create a user profile. Completer sample included all ITT participants that also completed the outcome survey.
Arm/Group Title ITT Sample Population Completers
Hide Arm/Group Description:

Subjects download & use the mobile application.

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.

ITT sample- completed the outcome survey
Overall Number of Participants Analyzed 416 365
Measure Type: Count of Participants
Unit of Measure: Participants
7-day abstinence
188
  45.2%
188
  51.5%
30-day abstinence
109
  26.2%
109
  29.9%
Time Frame 4 months
Adverse Event Reporting Description Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
 
Arm/Group Title Adverse Events
Hide Arm/Group Description Total Adverse Events
All-Cause Mortality
Adverse Events
Affected / at Risk (%)
Total   0/416 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Adverse Events
Affected / at Risk (%) # Events
Total   0/416 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events
Affected / at Risk (%) # Events
Total   19/416 (4.57%)    
Cardiac disorders   
Silent Myocardial Infarction * 1  1/416 (0.24%)  1
General disorders   
Nightmare * 1  1/416 (0.24%)  1
Pharyngitis * 1  1/416 (0.24%)  1
Decreased Mobility * 1  1/416 (0.24%)  1
Dental Discomfort * 1  1/416 (0.24%)  1
Nasopharyngitis * 1  1/416 (0.24%)  1
Emergency Care * 1  1/416 (0.24%)  1
Sciatica * 1  1/416 (0.24%)  1
Infections and infestations   
Kidney Infection * 1  1/416 (0.24%)  1
Injury, poisoning and procedural complications   
Hernia Obstructive * 1  1/416 (0.24%)  1
Nervous system disorders   
Fatigue * 1  3/416 (0.72%)  3
Migraine * 1  1/416 (0.24%)  1
Psychiatric disorders   
Mood Change * 1  2/416 (0.48%)  2
Stress * 1  1/416 (0.24%)  1
Surgical and medical procedures   
Hand Repair Operation * 1  1/416 (0.24%)  1
Surgery * 1  1/416 (0.24%)  1
1
Term from vocabulary, MedDRA 10.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Scientific Affairs
Organization: Click Therapeutics
Phone: 646-844-2158
Responsible Party: Click Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02656745     History of Changes
Other Study ID Numbers: 20152568
First Submitted: January 12, 2016
First Posted: January 15, 2016
Results First Submitted: September 12, 2018
Results First Posted: November 14, 2018
Last Update Posted: November 14, 2018