Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Study Details
Study Description
Brief Summary
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Treatment A (device Clickotine®) 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)
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.
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Sham Comparator: Treatment B (smoking education) 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)
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.
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Outcome Measures
Primary Outcome Measures
- Primary Outcome Measure: [[Time Frame: 8 week core study]]
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.
Secondary Outcome Measures
- Secondary Outcome Measure [[Time Frame: 8 week core study]]
A secondary objective of the study is to establish the feasibility of biochemical verification of smoking cessation in a fully remote, digital clinical trial.
- Secondary Outcome Measure [[Time Frame: 8 week core study]]
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.
- Secondary Outcome Measure [[Time Frame: 8 week core study]]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 to 65
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Smokes at least 5 cigarettes daily
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Is interested in quitting in the next 30 days
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Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher
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Willing and able to receive SMS text messages
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Able to comprehend the English-language and the informed consent form
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Lives in the United States
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One half of the study sample will be recruited from the general population of smokers via social media advertisements
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One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network
Exclusion Criteria:
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Prior use of Clickotine or QuitGuide
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Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Click Therapeutics | New York | New York | United States | 10013 |
Sponsors and Collaborators
- Click Therapeutics, Inc.
Investigators
- Study Chair: Shaheen Lakhan, MDPhD, FAAN, Click Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT-101-002