Innovative Digital Therapeutic for Smoking Cessation

May 12, 2022 updated by: My Digital Study

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • My Digital Study

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A Mobile Application
Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.
Device: CT-101-M
Mobile Application
Active Comparator: Treatment B Mobile Application
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
Device: QuitGuide
Mobile Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon completion of 8-week period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon completion of 8-week period
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.
Upon completion of 8-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

My Digital Study

Investigators

  • Principal Investigator: Brian M Iacoviello, PhD, My Digital Study

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Actual)

March 14, 2019

Study Completion (Actual)

March 14, 2019

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (Actual)

October 3, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-101-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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