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

NCT05440721 | Withdrawn DMC FDA Device

• 1 other identifier: CT-101-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Addiction; Drug Addiction; Drug Dependence; Substance Use Disorder; Tobacco Dependence

Keywords

Smoking; Cigarette Smoking; Tobacco Smoking; Nicotine; Drug; Addiction; Tobacco

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary Outcome Measure

  [Time Frame: 8 week core study]

• Secondary Outcome Measure

  [Time Frame: 8 week core study]

• Secondary Outcome Measure

  [Time Frame: 8 week core study]

Study Arms (2)

Treatment A (device Clickotine®)

ACTIVE COMPARATOR

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)

Treatment B (smoking education)

SHAM COMPARATOR

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)

Interventions

Treatment A with device Clickotine® (Active intervention) DEVICE

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 A (device Clickotine®)

Treatment B with smoking education (control) DEVICE

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.

Treatment B (smoking education)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead

Study Sites (1)

Click Therapeutics

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Substance-Related Disorders; Smoking; Cigarette Smoking; Tobacco Smoking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior; Tobacco Use; Compulsive Behavior; Impulsive Behavior

Study Officials

• Shaheen Lakhan, MDPhD, FAAN

  Click Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 1, 2022
• Study Start: October 25, 2018
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)