Innovative Digital Therapeutic for Smoking Cessation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-24

Study Completion Date

2019-03-14

Brief Summary

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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A Mobile Application

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

Group Type EXPERIMENTAL

CT-101-M

Intervention Type DEVICE

Mobile Application

Treatment B Mobile Application

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

Group Type ACTIVE_COMPARATOR

QuitGuide

Intervention Type DEVICE

Mobile Application

Interventions

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CT-101-M

Mobile Application

Intervention Type DEVICE

QuitGuide

Mobile Application

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No