An Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- Click Therapeutics, Inc.
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- The main outcome of the Clickotine Learning Study is to determine engagement with the digital intervention (DTx).
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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:
- •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)
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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 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 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
Secondary Outcomes
- The secondary outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention for cigarette users as compared to dual-users(4 Months)
- 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(4 Months)