NCT05440721

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Click Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Nicotine Addiction
• Drug Addiction
• Drug Dependence
• Substance Use Disorder
• Tobacco Dependence

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-10-25
• Primary completion: 2022-07-01
• Completion: 2022-08-01
• First posted: 2022-07-01
• Last updated: 2022-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study