Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
NCT ID: NCT05440721
Last Updated: 2022-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-10-25
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
2. Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
18 Years
65 Years
ALL
Yes
Sponsors
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Click Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shaheen Lakhan, MDPhD, FAAN
Role: STUDY_CHAIR
Click Therapeutics
Locations
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Click Therapeutics
New York, New York, United States
Countries
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Other Identifiers
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CT-101-002
Identifier Type: -
Identifier Source: org_study_id
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