Clinical Learning Study for a Mobile Smoking Cessation Program

NCT04857515 | Completed FDA Device

• 1 other identifier: CT-101-CLS-001
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Smoking Behaviors; Smoking Reduction; Smoking, Cigarette; Smoking; Nicotine Dependence

Keywords

Smoking Cessation; Smoking Cessation Program; Smoking Cessation Digital Therapeutic

Outcome Measures

Primary Outcomes (3)

• 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

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

  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

  4 Months

Study Arms (2)

Cigarette Smokers

Adult cigarette smokers who only smoke combustible cigarettes

Device: Clickotine®

Dual-Users

Adult smokers who smoke both combustible cigarettes and vape

Device: Clickotine®

Interventions

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.

Cigarette Smokers; Dual-Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age: 18+ US Resident Fluent in english

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead

Study Sites (1)

Click Therapeutics

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking; Smoking Reduction; Cigarette Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 23, 2021
• Study Start: March 12, 2021
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (1)