Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nicotine Addiction
- Sponsor
- Click Therapeutics, Inc.
- Locations
- 1
- Primary Endpoint
- Primary Outcome Measure:
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Primary Outcome Measure:
Time Frame: [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 Outcomes
- Secondary Outcome Measure([Time Frame: 8 week core study])