Nicotine AddictionNCT02656745
Clinical Trial of Smoking Cessation Mobile Phone Program
A study testing Mobile Smoking Cessation Solution in people with Nicotine Addiction and Drug Addiction, run by Click Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Addiction, Drug Addiction, Drug Dependence
- What is being tested?
- Mobile Smoking Cessation Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence
- Being tested
- Mobile Smoking Cessation Solution
- Keywords
- Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders, Smoking, Cigarette Smoking, Tobacco Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Smoking Cessation SolutionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Smoking Cessation Solution | Experimental | Subjects download \& use the mobile application. Receives: Device: Mobile Smoking Cessation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week core study
Secondary outcomes (2)
Number of Participants With Treatment-related Adverse Events
To evaluate the tolerability and safety of the application
Measured: 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.
Measured: 8 week core study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Schork, PhD, Principal investigator, J. Craig Venter InstituteTed Silver, Study director, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656745
- Sponsor's protocol ID
- 20152568
- Status last verified
- Sep 2018
- First submitted
- 12 Jan 2016
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28442453
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Mobile-Based Intervention for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02656745
- Acronym / sponsor ID
- 20152568
- Conditions
- Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence
- Keywords
- Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Smoking Cessation Solution | Experimental | Device: Mobile Smoking Cessation SolutionSubjects download \& use the mobile application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- Unable or unwilling to provide informed consent
- Responds appropriately to any item in the Eligibility Questionnaire:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Smoking Cessation SolutionThe 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. | Device | Mobile Smoking Cessation Solution |
Primary outcome
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.
2 secondary outcomes
Number of Participants With Treatment-related Adverse Events
Time frame: 8 week core study
Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]
Time frame: 8 week core study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28442453Iacoviello 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Schork, PhD principal investigator
J. Craig Venter Institute
Ted Silver study director
Click Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Smoking Cessation Solution in people with Nicotine Addiction and Drug Addiction, run by Click Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Remain Active Users of the Program (time frame: 8 week core study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.