Innovative Digital Therapeutic for Smoking Cessation

My Digital Study

Status: Completed

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

Treatments: Device: QuitGuide; Device: CT-101-M

Study type: Interventional

Funder types: Industry

Identifiers

NCT03694327

CT-101-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups

Treatment A Mobile Application

Experimental group

Description:

Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.

Treatment:

Device: CT-101-M

Treatment B Mobile Application

Active Comparator group

Description:

Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.

Treatment:

Device: QuitGuide