An interventional study of Mobile Smoking Cessation Solution in Nicotine Addiction, Drug Addiction and Drug Dependence, sponsored by Click Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Click Therapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 416 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Click Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Responds appropriately to any item in the Eligibility Questionnaire:
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.
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.
Time frame: 8 week core study
Number of Participants With Treatment-related Adverse Events
To evaluate the tolerability and safety of the application
Time frame: 8 week core study
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
To assess whether continued user engagement is correlated with smoking cessation and behaviors.
Time frame: 8 week core study
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.
| Milestone | Mobile Smoking Cessation Solution |
|---|---|
| Started | 416 |
| Completed | 416 |
| Not completed | 0 |
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.
| Participants | Mobile Smoking Cessation Solution |
|---|---|
| Number of Participants Who Remain Active Users of the Program | 365 |
To evaluate the tolerability and safety of the application
| Participants | Adverse Events |
|---|---|
| Number of Participants With Treatment-related Adverse Events | 19 |
To assess whether continued user engagement is correlated with smoking cessation and behaviors.
| Participants | ITT Sample Population | Completers |
|---|---|---|
| 7-day abstinence | 188 | 188 |
| 30-day abstinence | 109 | 109 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events | 0/416 (0%) | 0/416 (0%) | 19/416 (4.6%) |
| Event | Adverse Events |
|---|---|
| FatigueNervous system disorders | 3/416 |
| Mood ChangePsychiatric disorders | 2/416 |
| NightmareGeneral disorders | 1/416 |
| PharyngitisGeneral disorders | 1/416 |
| Decreased MobilityGeneral disorders | 1/416 |
| Silent Myocardial InfarctionCardiac disorders | 1/416 |
| StressPsychiatric disorders | 1/416 |
| Hand Repair OperationSurgical and medical procedures | 1/416 |
| Dental DiscomfortGeneral disorders | 1/416 |
| Kidney InfectionInfections and infestations | 1/416 |
| Age, Continuous(years) | Mobile Smoking Cessation Solution |
|---|---|
| Mean | 36 ± 10.8 |
| Sex: Female, Male(Participants) | Mobile Smoking Cessation Solution |
|---|---|
| Female | 247 |
| Male | 169 |
| Race/Ethnicity, Customized(Participants) | Mobile Smoking Cessation Solution |
|---|---|
| White | 315 |
| Hispanic | 37 |
| African American | 22 |
| Asian or Pacific Islander | 11 |
| Native American | 5 |
| Other | 26 |
| Region of Enrollment(participants) | Mobile Smoking Cessation Solution |
|---|---|
| United States | 416 |
Plan to share: No
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Click Therapeutics, Inc.