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OpenTrials
Completed

NCT Number: NCT04857515

Clinical Learning Study for a Mobile Smoking Cessation Program

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.

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Cigarette Smoking Health Behavior Mental Disorders Nicotine Dependence Smoking Smoking Behaviors Smoking Reduction Smoking, Cigarette Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Click Therapeutics

New York, 10013, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Click Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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