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Clinical Learning Study for a Mobile Smoking Cessation Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857515
Recruitment Status : Completed
First Posted : April 23, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Click Therapeutics, Inc.

Tracking Information
First Submitted Date April 1, 2021
First Posted Date April 23, 2021
Last Update Posted Date August 17, 2021
Actual Study Start Date March 12, 2021
Actual Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2021)
  • 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 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 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
Original Primary Outcome Measures
 (submitted: April 20, 2021)
  • 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 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 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.
Change History
Current Secondary Outcome Measures
 (submitted: August 11, 2021)
  • 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 [ Time Frame: 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 [ Time Frame: 4 Months ]
    Acceptability of the digital intervention will be evaluated via survey
Original Secondary Outcome Measures
 (submitted: April 20, 2021)
  • 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. [ Time Frame: 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. [ Time Frame: 4 Months ]
    Acceptability of the digital intervention will be evaluated via survey.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Learning Study for a Mobile Smoking Cessation Program
Official Title An Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Age: 18+ US Resident Fluent in english
Condition
  • Smoking Cessation
  • Smoking Behaviors
  • Smoking Reduction
  • Smoking, Cigarette
  • Smoking
  • Nicotine Dependence
Intervention 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.
Study Groups/Cohorts
  • Cigarette Smokers
    Adult cigarette smokers who only smoke combustible cigarettes
    Intervention: Device: Clickotine®
  • Dual-Users
    Adult smokers who smoke both combustible cigarettes and vape
    Intervention: Device: Clickotine®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 11, 2021)
78
Original Estimated Enrollment
 (submitted: April 20, 2021)
75
Actual Study Completion Date June 28, 2021
Actual Primary Completion Date June 28, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04857515
Other Study ID Numbers CT-101-CLS-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Click Therapeutics, Inc.
Study Sponsor Click Therapeutics, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Click Therapeutics, Inc.
Verification Date August 2021