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

Primary Purpose

Nicotine Addiction, Drug Addiction, Drug Dependence

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment A with device Clickotine® (Active intervention)
Treatment B with smoking education (control)
Sponsored by
Click Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Addiction focused on measuring Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Click Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment A (device Clickotine®)

Treatment B (smoking education)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
June 22, 2022
Last Updated
June 27, 2022
Sponsor
Click Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05440721
Brief Title
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Official Title
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Change of company's priority; learning from a separate CT-101-CLS-001 (NCT04857515) is deemed sufficient
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence
Keywords
Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A (device Clickotine®)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment B (smoking education)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Treatment A with device Clickotine® (Active intervention)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Treatment B with smoking education (control)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome Measure:
Description
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 Information:
Title
Secondary Outcome Measure
Description
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]
Title
Secondary Outcome Measure
Description
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]
Title
Secondary Outcome Measure
Description
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]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 to 65 Smokes at least 5 cigarettes daily Is interested in quitting in the next 30 days Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher Willing and able to receive SMS text messages Able to comprehend the English-language and the informed consent form Lives in the United States One half of the study sample will be recruited from the general population of smokers via social media advertisements One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network Exclusion Criteria: Prior use of Clickotine or QuitGuide Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen Lakhan, MDPhD, FAAN
Organizational Affiliation
Click Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Click Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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