Clinical Trial of Smoking Cessation Mobile Phone Program
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Who Remain Active Users of the Program [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.
Secondary Outcome Measures
- Number of Participants With Treatment-related Adverse Events [8 week core study]
To evaluate the tolerability and safety of the application
- Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] [8 week core study]
To assess whether continued user engagement is correlated with smoking cessation and behaviors.
Eligibility Criteria
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:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Click Therapeutics | New York | New York | United States | 10013 |
Sponsors and Collaborators
- Click Therapeutics, Inc.
Investigators
- Principal Investigator: Nicholas Schork, PhD, J. Craig Venter Institute
- Study Director: Ted Silver, Click Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20152568
Study Results
Participant Flow
| 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 Detail | 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 |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Mobile Smoking Cessation Solution |
|---|---|
| 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 Participants | 416 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
36
(10.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
247
59.4%
|
| Male |
169
40.6%
|
| Race/Ethnicity, Customized (Count of 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 (participants) [Number] | |
| United States |
416
100%
|
Outcome Measures
| Title | Number of Participants Who Remain Active Users of the Program |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 416 participants ultimately downloaded the app and constituted the ITT population. |
| Arm/Group Title | Mobile Smoking Cessation Solution |
|---|---|
| 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. |
| Measure Participants | 416 |
| Count of Participants [Participants] |
365
87.7%
|
| Title | Number of Participants With Treatment-related Adverse Events |
|---|---|
| Description | To evaluate the tolerability and safety of the application |
| Time Frame | 8 week core study |
Outcome Measure Data
| Analysis Population Description |
|---|
| 416 participants ultimately downloaded the app and constituted the ITT population. |
| Arm/Group Title | Adverse Events |
|---|---|
| Arm/Group Description | Total Adverse Events |
| Measure Participants | 416 |
| Number [Participants] |
19
4.6%
|
| Title | Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] |
|---|---|
| Description | To assess whether continued user engagement is correlated with smoking cessation and behaviors. |
| Time Frame | 8 week core study |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 416 | 365 |
| 7-day abstinence |
188
45.2%
|
188
NaN
|
| 30-day abstinence |
109
26.2%
|
109
NaN
|
Adverse Events
| 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 | |
| Arm/Group Description | Total Adverse Events | |
All Cause Mortality |
||
| Adverse Events | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/416 (0%) | |
Serious Adverse Events |
||
| Adverse Events | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/416 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Adverse Events | ||
| Affected / at Risk (%) | # Events | |
| Total | 19/416 (4.6%) | |
| Cardiac disorders | ||
| Silent Myocardial Infarction | 1/416 (0.2%) | 1 |
| General disorders | ||
| Nightmare | 1/416 (0.2%) | 1 |
| Pharyngitis | 1/416 (0.2%) | 1 |
| Decreased Mobility | 1/416 (0.2%) | 1 |
| Dental Discomfort | 1/416 (0.2%) | 1 |
| Nasopharyngitis | 1/416 (0.2%) | 1 |
| Emergency Care | 1/416 (0.2%) | 1 |
| Sciatica | 1/416 (0.2%) | 1 |
| Infections and infestations | ||
| Kidney Infection | 1/416 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||
| Hernia Obstructive | 1/416 (0.2%) | 1 |
| Nervous system disorders | ||
| Fatigue | 3/416 (0.7%) | 3 |
| Migraine | 1/416 (0.2%) | 1 |
| Psychiatric disorders | ||
| Mood Change | 2/416 (0.5%) | 2 |
| Stress | 1/416 (0.2%) | 1 |
| Surgical and medical procedures | ||
| Hand Repair Operation | 1/416 (0.2%) | 1 |
| Surgery | 1/416 (0.2%) | 1 |
Limitations/Caveats
More Information
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 |
| brian@clicktherapeutics.com |
- 20152568