Innovative Digital Therapeutic for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694327
• Other study ID #: CT-101-002
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: March 14, 2019

Study information

• Verified date: May 2022
• Source: My Digital Study
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: March 14, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Behavior, Addictive
• Disease
• Drug Addiction
• Drug Dependence
• Nicotine Addiction
• Smoking Cessation
• Substance Use Disorder
• Substance-Related Disorders
• Tobacco Dependence
• Tobacco Smoking
• Tobacco Use Disorder

Intervention

Device:
• CT-101-M
Mobile Application
• QuitGuide
Mobile Application

Locations

Country	Name	City	State
United States	My Digital Study	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
My Digital Study

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-Day Sustained Abstinence From Smoking	Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.	Upon completion of 8-week period
Secondary	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.	Upon completion of 8-week period
Secondary	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.	Upon completion of 8-week period