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

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

Detailed Description
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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.

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

Conditions
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Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence

Intervention / Treatment
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* Device: Treatment A with device Clickotine® (Active intervention)
* Device: Treatment B with smoking education (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 Smokes at least 5 cigarettes daily Is interested in quitting in the next 30 days Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher Willing and able to receive SMS text messages Able to comprehend the English-language and the informed consent form Lives in the United States One half of the study sample will be recruited from the general population of smokers via social media advertisements One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network Exclusion Criteria: Prior use of Clickotine or QuitGuide Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A (device Clickotine®)<br>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. | Device: Treatment A with device Clickotine® (Active intervention)<br>* The intervention regimen around Treatment A is almost entirely user-directed. When a person has a craving, a series of options are available to ease the craving and resist the urge to smoke. The user will also engage with Clickotine® leading up to their quit date to complete a program of 21 Missions, daily activities which help prepare them to quit and keep them off cigarettes. Ideally, the user will open and use Treatment A several times a day.<br>|
| Sham Comparator: Treatment B (smoking education)<br>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. | Device: Treatment B with smoking education (control)<br>* The Treatment B app is operated by the National Cancer Institute to provide education and support to smokers seeking to quit. The QG regimen is entirely user-directed. When a user has a craving or wants support or education, they can log into the QG app. The QG app also provides lessons relevant for preparing to quit and beginning to quit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure: | The primary objective is to confirm the improved efficacy of CKT for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs. QuitGuide. **Acceptance criteria: Self-reported 30 day point prevalence quit rates will be significantly higher in the CKT arm than QuitGuide. | [Time Frame: 8 week core study] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measure | A secondary objective of the study is to establish the feasibility of biochemical verification of smoking cessation in a fully remote, digital clinical trial. | [Time Frame: 8 week core study] | 
| Secondary Outcome Measure | A secondary objective of the study is to compare cessation rates between the CKT+NRT group and the CKT-only group, to address expected med/NRT use during the trial and to confirm the initial trial result that CKT+NRT is not superior to CKT-alone. | [Time Frame: 8 week core study] | 
| Secondary Outcome Measure | A secondary objective of the study is to demonstrate the feasibility of evaluating CKT in a Magellan Behavioral Health (A Click Therapeutics partner) value-based care population | [Time Frame: 8 week core study] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco