Skip to main content
OpenTrials
Completed

NCT Number: NCT03694327

Innovative Digital Therapeutic for Smoking Cessation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Drug Addiction Drug Dependence Health Behavior Mental Disorders Nicotine Addiction Smoking Substance Use Disorder Substance-Related Disorders Tobacco Dependence Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

My Digital Study

New York, 10013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CT-101-M

Device

Mobile Application

QuitGuide

Device

Mobile Application

Primary outcomes

  1. 30-Day Sustained Abstinence From Smoking

    Time frame: Upon completion of 8-week period

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

Secondary outcomes

  1. Feasibility of Biochemical Verification of Smoking Cessation

    Time frame: 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.

  2. NRT and Smoking Cessation Pharmacotherapy Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

My Digital Study

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2018
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.