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

Sponsor
Click Therapeutics, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT05440721
Collaborator
(none)
0
1
2
45.2
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Treatment A with device Clickotine® (Active intervention)
  • Device: Treatment B with smoking education (control)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Actual Study Start Date :
Oct 25, 2018
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Secondary Outcome Measure [[Time Frame: 8 week core study]]

    A secondary objective of the study is to establish the feasibility of biochemical verification of smoking cessation in a fully remote, digital clinical trial.

  2. Secondary Outcome Measure [[Time Frame: 8 week core study]]

    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.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Click Therapeutics New York New York United States 10013

Sponsors and Collaborators

  • Click Therapeutics, Inc.

Investigators

  • Study Chair: Shaheen Lakhan, MDPhD, FAAN, Click Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Click Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05440721
Other Study ID Numbers:
  • CT-101-002
First Posted:
Jul 1, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Click Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022