Clinical trial NCT04857515: Clinical Learning Study for a Mobile Smoking Cessation Program
Official title: An Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Smoking Behaviors
Smoking Reduction
Smoking, Cigarette
Smoking
Nicotine Dependence
Keywords: Smoking Cessation
Smoking Cessation Program
Smoking Cessation Digital Therapeutic
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age: 18+ US Resident Fluent in english

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.


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.
* 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

Primary outcomes:
measure: The main outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention (DTx).
timeFrame: 4 Months
measure: The main outcome of the Clickotine Learning Study is to determine engagement with the digital intervention (DTx).
timeFrame: 4 Months
measure: The main outcome of the Clickotine Learning Study is to evaluate attitudes and beliefs regarding the digital intervention.
timeFrame: 4 Months
Secondary outcomes:
measure: 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
timeFrame: 4 Months
measure: The secondary outcome of the Clickotine Learning Study is to determine acceptability of the digital intervention for cigarette users as compared to dual-users
timeFrame: 4 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
References: