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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.

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.

Condition or disease Intervention/treatment
Smoking Cessation Smoking Behaviors Smoking Reduction Smoking, Cigarette Smoking Nicotine Dependence Device: Clickotine®

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Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic
Actual Study Start Date : March 12, 2021
Actual Primary Completion Date : June 28, 2021
Actual Study Completion Date : June 28, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age: 18+ US Resident Fluent in english
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857515


Locations
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United States, New York
Click Therapeutics
New York, New York, United States, 10013
Sponsors and Collaborators
Click Therapeutics, Inc.
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Responsible Party: Click Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04857515    
Other Study ID Numbers: CT-101-CLS-001
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021

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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
Keywords provided by Click Therapeutics, Inc.:
Smoking Cessation
Smoking Cessation Program
Smoking Cessation Digital Therapeutic
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders