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Change of company's priority; learning from a separate CT-101-CLS-001 (NCT04857515) is deemed sufficient
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (device Clickotine®) | Active Comparator | 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. |
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| Treatment B (smoking education) | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A with device Clickotine® (Active intervention) | Device | 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. |
| 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] |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Lakhan, MDPhD, FAAN | Click Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
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| Treatment B with smoking education (control) | Device | 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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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] |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D019966 | Substance-Related Disorders |
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| D000073869 | Tobacco Smoking |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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