Clinical Learning Study for a Mobile Smoking Cessation Program

Recruitment & Eligibility

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.
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

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Cigarette Smokers	Clickotine®	Adult cigarette smokers who only smoke combustible cigarettes
Dual-Users	Clickotine®	Adult smokers who smoke both combustible cigarettes and vape

Primary Outcome Measures

Name	Time	Method
The main outcome of the Clickotine Learning Study is to determine engagement with the digital intervention (DTx).	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).	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.	4 Months	Attitudes and beliefs regarding the digital intervention will be evaluated by interview for selected participants

Secondary Outcome Measures

Name	Time	Method
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	These engagement levels will be measured via app use.
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	Acceptability of the digital intervention will be evaluated via survey

Recruitment & Eligibility