Innovative Digital Therapeutic for Smoking Cessation

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 12, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

30-Day Sustained Abstinence from Smoking[ Time Frame: Upon completion of 8-week period ]

Self-reported Abstinence from smoking on the 8-Week Outcome Survey

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Feasibility of biochemical verification of smoking cessation[ Time Frame: Upon completion of 8-week period ]
Concordance between self-reported abstinence and measurement of exhaled carbon monoxide (CO) of <7ppm at study outcome will be assessed.
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.

Descriptive Information

Brief Title ^ICMJE

Innovative Digital Therapeutic for Smoking Cessation

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Device: Treatment A Digital Intervention
Mobile Application
Device: Treatment B Digital Intervention
Mobile Application

Study Arms

Experimental: Treatment A Mobile Application
Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.
Active Comparator: Treatment B Mobile Application
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

195

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2019

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

My Digital Study

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Brian M Iacoviello, PhD My Digital Study

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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