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

Not Applicable

Withdrawn

• Conditions: Nicotine Addiction; Drug Addiction; Tobacco Dependence; Drug Dependence; Substance Use Disorder
• Interventions: Device: Treatment B with smoking education (control); Device: Treatment A with device Clickotine® (Active intervention)

• Registration Number: NCT05440721
• Lead Sponsor: Click Therapeutics, Inc.

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.

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 Timeline

• Study Start: 2018-10-25
• Status Verified: 2022-06
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Primary Completion: 2022-07
• Study First Posted: 2022-07-01
• Last Update Posted: 2022-07-01
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 18 to 65
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

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Exclusion Criteria

1. Prior use of Clickotine or QuitGuide
2. Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B (smoking education)	Treatment B with smoking education (control)	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 A (device Clickotine®)	Treatment A with device Clickotine® (Active intervention)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Click Therapeutics; 🇺🇸 New York, New York, United States