Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification

Click Therapeutics

Status: Withdrawn

Conditions: Tobacco Dependence; Drug Dependence; Nicotine Addiction; Substance Use Disorder; Drug Addiction

Treatments: Device: Treatment B with smoking education (control); Device: Treatment A with device Clickotine® (Active intervention)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05440721

CT-101-002

Details and patient eligibility

About

This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.

Full description

The overarching study aim is to recruit a population of current smokers who are motivated to quit with the assistance of a mobile solution, enroll them into a study testing apps to help them quit, and randomize them into one of two arms. The core study period will consist of 8 weeks of usage of Treatment A or Treatment B. At the end of this period, users will receive notifications to link them to an online survey, which will record their responses in a secure database.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 to 65
2. Smokes at least 5 cigarettes daily
3. Is interested in quitting in the next 30 days
4. Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher
5. Willing and able to receive SMS text messages
6. Able to comprehend the English-language and the informed consent form
7. Lives in the United States
8. One half of the study sample will be recruited from the general population of smokers via social media advertisements
9. One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network

Exclusion criteria

1. Prior use of Clickotine or QuitGuide
2. Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Treatment A (device Clickotine®)

Active Comparator group

Description:

User will open and use Treatment A (Clickotine® device) several times a day up to their quit date to complete a program of 21 Missions.

Treatment:

Device: Treatment A with device Clickotine® (Active intervention)

Treatment B (smoking education)

Sham Comparator group

Description:

Treatment B app provides education and support to smokers seeking to quit. When a user has a craving or wants support or education, they can log into the app.

Treatment:

Device: Treatment B with smoking education (control)