Smoking CessationNCT04857515
Clinical Learning Study for a Mobile Smoking Cessation Program
An observational study of Smoking Cessation and Smoking Behaviors, run by Click Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study are to obtain learnings regarding the Digital Therapeutic (DTx) experience of Clickotine, including acceptability and preference of the overall program and specific DTx components, as well as to obtain learnings related to adult participants' use of the DTx for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking Behaviors, Smoking Reduction
- What is being tested?
- Clickotine®
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2021to 28 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age: 18+ US Resident Fluent in english
Who may be able to join
- Signed informed consent.
- Age 18 and older.
- For cigarette smokers: Smokes at least 5 cigarettes a day. For dual-users: Smokes cigarettes AND uses e-cigarettes, with the following additional criteria:
- Smokes at least 5 cigarettes a day
- Vaping sessions, when they occur, must be for at least 10 minutes (15 puffs)
- Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form)
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- Lives in the United States.
- Is the solo user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities.
- Has an active email address.
- Willing and able to receive SMS text messages on their smartphone and email messages.
- Have access to internet connection during the study duration.
- Able to confirm download of installed DTx on baseline date.
- Willing and able to comply with study protocol and assessments.
- Is willing and able to self-identify sessions of cigarette smoking (1 or more consecutive cigarettes) or vaping (approximately 15 puffs or around 10 minutes in duration) and log those sessions.
- Self-reported comfort with and ability to use smartphone apps/programs.
Who cannot join
- Prior use of Clickotine.
- Currently using a software app for smoking cessation.
- Lifetime diagnosis of schizophrenia, psychotic disorder, or pervasive developmental disorders, as per participant self-report.
- Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrine, neurologic (including history of severe head injury with loss of consciousness), immunologic, or hematologic disease, as per participant self-report.
- Other significant medical condition that, in the opinion of the Investigator or study sponsor, may cofound the interpretation of device efficacy, safety, and tolerability.
- Current use of tobacco-containing products other than cigarettes or e-cigarettes (e.g. snuff, chewing tobacco, cigars, or pipes).
- Does not have or is unwilling to create a PayPal account
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic
The purpose of this study are to obtain learnings regarding the Digital Therapeutic (DTx) experience of Clickotine, including acceptability and preference of the overall program and specific DTx components, as well as to obtain learnings related to adult participants' use of the DTx for smoking cessation.
- Conditions
- Smoking Cessation, Smoking Behaviors, Smoking Reduction, Smoking, Cigarette, Smoking, Nicotine Dependence
- Being tested
- Clickotine®
- Keywords
- Smoking Cessation, Smoking Cessation Program, Smoking Cessation Digital Therapeutic
- Medical subject headings
- Smoking Cessation, Smoking, Smoking Reduction, Cigarette Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clickotine®Device
Clickotine is a DTx that contains behavior modification techniques that include controlled breathing, social engagement, personalized messaging, medication access and adherence, digital diversions, and financial incentives.
| Study group | Role | What they receive |
|---|---|---|
| Cigarette Smokers | Adult cigarette smokers who only smoke combustible cigarettes Receives: Device: Clickotine® | |
| Dual-Users | Adult smokers who smoke both combustible cigarettes and vape Receives: Device: Clickotine® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention (DTx).
General acceptability of the DTx will be evaluated via surveys for all participants
Measured: 4 Months
The main outcome of the Clickotine Learning Study is to determine engagement with the digital intervention (DTx).
Engagement with the digital intervention will be measured via app use for all participants
Measured: 4 Months
The main outcome of the Clickotine Learning Study is to evaluate attitudes and beliefs regarding the digital intervention.
Attitudes and beliefs regarding the digital intervention will be evaluated by interview for selected participants
Measured: 4 Months
Secondary outcomes (2)
The secondary outcome of the Clickotine Learning Study is to measure engagement levels with the digital intervention for cigarette smokers as compared to dual-users
These engagement levels will be measured via app use.
Measured: 4 Months
The secondary outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention for cigarette users as compared to dual-users
Acceptability of the digital intervention will be evaluated via survey
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start12 Mar 2021
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857515
- Sponsor's protocol ID
- CT-101-CLS-001
- Status last verified
- Aug 2021
- First submitted
- 1 Apr 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic
- ClinicalTrials.gov ID
- NCT04857515
- Acronym / sponsor ID
- CT-101-CLS-001
- Conditions
- Smoking Cessation, Smoking Behaviors, Smoking Reduction, Smoking, Cigarette, Smoking, Nicotine Dependence
- Keywords
- Smoking Cessation, Smoking Cessation Program, Smoking Cessation Digital Therapeutic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study are to obtain learnings regarding the Digital Therapeutic (DTx) experience of Clickotine, including acceptability and preference of the overall program and specific DTx components, as well as to obtain learnings related to adult participants' use of the DTx for smoking cessation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cigarette Smokers | – | Device: Clickotine®Adult cigarette smokers who only smoke combustible cigarettes |
| Dual-Users | – | Device: Clickotine®Adult smokers who smoke both combustible cigarettes and vape |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age: 18+ US Resident Fluent in english
Key inclusion criteria (15 listed)
- Signed informed consent.
- Age 18 and older.
- For cigarette smokers: Smokes at least 5 cigarettes a day. For dual-users: Smokes cigarettes AND uses e-cigarettes, with the following additional criteria:
- Fluent in written and spoken English (confirmed by ability to read and comprehend the informed consent form)
- Lives in the United States.
Key exclusion criteria (7 listed)
- Prior use of Clickotine.
- Currently using a software app for smoking cessation.
- Lifetime diagnosis of schizophrenia, psychotic disorder, or pervasive developmental disorders, as per participant self-report.
- Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrine, neurologic (including history of severe head injury with loss of consciousness), immunologic, or hematologic disease, as per participant self-report.
- Other significant medical condition that, in the opinion of the Investigator or study sponsor, may cofound the interpretation of device efficacy, safety, and tolerability.
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 |
|---|---|---|
| Clickotine®Clickotine is a DTx that contains behavior modification techniques that include controlled breathing, social engagement, personalized messaging, medication access and adherence, digital diversions, and financial incentives. | Device | Cigarette Smokers, Dual-Users |
Primary outcome
The main outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention (DTx).
Time frame: 4 Months
General acceptability of the DTx will be evaluated via surveys for all participants
The main outcome of the Clickotine Learning Study is to determine engagement with the digital intervention (DTx).
Time frame: 4 Months
Engagement with the digital intervention will be measured via app use for all participants
The main outcome of the Clickotine Learning Study is to evaluate attitudes and beliefs regarding the digital intervention.
Time frame: 4 Months
Attitudes and beliefs regarding the digital intervention will be evaluated by interview for selected participants
2 secondary outcomes
The secondary outcome of the Clickotine Learning Study is to measure engagement levels with the digital intervention for cigarette smokers as compared to dual-users
Time frame: 4 Months
The secondary outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention for cigarette users as compared to dual-users
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Smoking Behaviors, 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 15 inclusion and 7 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 17 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The main outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention (DTx). (time frame: 4 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2021.