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

This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Click Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment A (device Clickotine®); 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.	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.
Sham Comparator: Treatment B (smoking education); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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]

Secondary Outcome Measures

Outcome Measure	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	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]

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Smoking; Tobacco; Addiction; Nicotine; Tobacco Smoking; Drug; Cigarette Smoking
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Tobacco Use Disorder; Behavior, Addictive
• Other Study ID Numbers: CT-101-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No