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Innovative Digital Therapeutic for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694327
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : June 6, 2022
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
My Digital Study

Study Description
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Brief Summary:
This study is comparing the efficacy of two smoking cessation apps.

Condition or disease Intervention/treatment Phase
Smoking Cessation Nicotine Addiction Drug Addiction Drug Dependence Tobacco Dependence Tobacco Use Disorder Substance Use Disorder Tobacco Smoking Device: CT-101-M Device: QuitGuide Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : March 14, 2019
Actual Study Completion Date : March 14, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694327


Locations
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United States, New York
My Digital Study
New York, New York, United States, 10013
Sponsors and Collaborators
My Digital Study
Investigators
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Principal Investigator: Brian M Iacoviello, PhD My Digital Study
  Study Documents (Full-Text)

Documents provided by My Digital Study:
Study Protocol  [PDF] March 10, 2022
Statistical Analysis Plan  [PDF] March 10, 2022

More Information
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Responsible Party: My Digital Study
ClinicalTrials.gov Identifier: NCT03694327    
Other Study ID Numbers: CT-101-002
First Posted: October 3, 2018    Key Record Dates
Results First Posted: June 6, 2022
Last Update Posted: June 6, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Tobacco Use Disorder
Behavior, Addictive
Pathologic Processes
 Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders