Innovative Digital Therapeutic for Smoking Cessation

Study Overview
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Brief Summary
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This study is comparing the efficacy of two smoking cessation apps.

Detailed Description
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Given that tobacco smoking is the leading cause of preventable death in the US, the development of effective cessation programs is critical; mobile phone applications represent a novel, accessible platform for helping smokers quit. This research project seeks to compare the efficacy of two smoking cessation apps. In a blinded, randomized, controlled study, current smokers motivated to quit will use a smoking cessation app for 8 weeks.

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

Conditions
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Smoking Cessation, Nicotine Addiction, Drug Addiction, Drug Dependence, Tobacco Dependence, Tobacco Use Disorder, Substance Use Disorder, Tobacco Smoking

Intervention / Treatment
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* Device: CT-101-M
* Device: QuitGuide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18 to 65 Fluent in written and spoken English (confirmed by ability to read and comprehend Informed Consent Form) Lives in the United States Smokes at least 5 cigarettes daily Is interested in quitting in the next 30 days The participant owns and has access to an iPhone with iOS 9 or greater capabilities, or an Android with OS 7 or greater capabilities The participant is willing and able to receive SMS text messages on their smartphone The participant is willing and able to receive email messages. Ability to confirm download of installed treatment arm app via telephone on randomization date. 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 form a Magellan Behavioral Health value-based care network Exclusion Criteria: Prior use of Treatment A Digital Intervention or Treatment B Digital Intervention Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A Mobile Application<br>Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation. | Device: CT-101-M<br>* Mobile Application<br>|
| Active Comparator: Treatment B Mobile Application<br>Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation. | Device: QuitGuide<br>* Mobile Application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day Sustained Abstinence From Smoking | Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey. | Upon completion of 8-week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Biochemical Verification of Smoking Cessation | Confirmation with the remote CO assessment was conducted to assess concordance between self-report and remote CO assessment results. Abstinence as per the CO assessment was defined as an iCO reading of fewer than 7ppm exhaled CO. | Upon completion of 8-week period | 
| NRT and Smoking Cessation Pharmacotherapy Use | Self-reported NRT and smoking cessation pharmacotherapy use will be acquired via the outcome survey. Cessation rates will be compared between those using/not using pharmacotherapy. | Upon completion of 8-week period |