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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
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.
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.
Click Therapeutics
New York, New York, United States
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: [Time Frame: 8 week core study]
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: [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: [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: [Time Frame: 8 week core study]
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