Innovative Digital Therapeutic for Smoking Cessation

My Digital Study158 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

158

Conditions

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

Interventions

CT-101-MDEVICE

Mobile Application

QuitGuideDEVICE

Mobile Application

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

My Digital Study

New York, New York, United States

Outcomes

Primary Outcomes

30-Day Sustained Abstinence From Smoking

Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.

Time frame: Upon completion of 8-week period

Secondary Outcomes

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.

Time frame: 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.

Time frame: Upon completion of 8-week period

Data from ClinicalTrials.gov

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