Clinical Learning Study for a Mobile Smoking Cessation Program

An Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation; Smoking Reduction; Nicotine Dependence; Smoking, Cigarette; Smoking Behaviors
• Intervention / Treatment: Device: Clickotine®

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Click Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Age: 18+ US Resident Fluent in english

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cigarette Smokers; Adult cigarette smokers who only smoke combustible cigarettes	Device: Clickotine®; 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.
Dual-Users; Adult smokers who smoke both combustible cigarettes and vape	Device: Clickotine®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Acceptability of the digital intervention will be evaluated via survey	4 Months

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2021
• Primary Completion (ACTUAL): June 28, 2021
• Study Completion (ACTUAL): June 28, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (ACTUAL): April 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Smoking Cessation; Smoking Cessation Program; Smoking Cessation Digital Therapeutic
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: CT-101-CLS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No