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Innovative Digital Therapeutic for Smoking Cessation

Primary Purpose

Smoking Cessation, Nicotine Addiction, Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT-101-M
QuitGuide
Sponsored by
My Digital Study
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • My Digital Study

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment A Mobile Application

Treatment B Mobile Application

Arm Description

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

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

Outcomes

Primary Outcome Measures

30-Day Sustained Abstinence From Smoking
Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 12, 2018
Last Updated
May 12, 2022
Sponsor
My Digital Study
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1. Study Identification

Unique Protocol Identification Number
NCT03694327
Brief Title
Innovative Digital Therapeutic for Smoking Cessation
Official Title
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
March 14, 2019 (Actual)
Study Completion Date
March 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
My Digital Study

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Nicotine Addiction, Drug Addiction, Drug Dependence, Tobacco Dependence, Tobacco Use Disorder, Substance Use Disorder, Tobacco Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A Mobile Application
Arm Type
Experimental
Arm Description
Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.
Arm Title
Treatment B Mobile Application
Arm Type
Active Comparator
Arm Description
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
Intervention Type
Device
Intervention Name(s)
CT-101-M
Intervention Description
Mobile Application
Intervention Type
Device
Intervention Name(s)
QuitGuide
Intervention Description
Mobile Application
Primary Outcome Measure Information:
Title
30-Day Sustained Abstinence From Smoking
Description
Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.
Time Frame
Upon completion of 8-week period
Secondary Outcome Measure Information:
Title
Feasibility of Biochemical Verification of Smoking Cessation
Description
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
Title
NRT and Smoking Cessation Pharmacotherapy Use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Iacoviello, PhD
Organizational Affiliation
My Digital Study
Official's Role
Principal Investigator
Facility Information:
Facility Name
My Digital Study
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Innovative Digital Therapeutic for Smoking Cessation

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