Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette Smokers | Adult cigarette smokers who only smoke combustible cigarettes |
| |
| Dual-Users | Adult smokers who smoke both combustible cigarettes and vape |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Not provided
Inclusion Criteria:
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.
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Age: 18+ US Resident Fluent in english
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 25, 2022 | |
| Reset | Apr 28, 2023 | |
| Release | May 7, 2025 | |
| Reset | May 21, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2022 | Apr 28, 2023 | |||
| May 7, 2025 |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D000074264 | Smoking Reduction |
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
Not provided
Not provided
Not provided
Not provided
Not provided
Acceptability of the digital intervention will be evaluated via survey |
| 4 Months |
| May 21, 2025 |
| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |