Innovative Digital Therapeutic for Smoking Cessation

Not Applicable

Completed

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

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

Detailed Description: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Treatment B Mobile Application	QuitGuide	Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
Treatment A Mobile Application	CT-101-M	Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Feasibility of Biochemical Verification of Smoking Cessation	Upon completion of 8-week period	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.
NRT and Smoking Cessation Pharmacotherapy Use	Upon completion of 8-week period	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.