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

Tobacco Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05440721
• Other study ID #: CT-101-002
• Status: Withdrawn
• Phase: N/A
• Start date: October 25, 2018
• Est. completion date: August 2022

Study information

• Verified date: June 2022
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Exclusion Criteria:

1. Prior use of Clickotine or QuitGuide

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Drug Addiction
• Drug Dependence
• Nicotine Addiction
• Substance Use Disorder
• Substance-Related Disorders
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Secondary	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	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: 8 week core study]
Secondary	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]