Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-05 @ 5:11 AM
Study NCT ID:
NCT03142932
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C2Q
Brief Summary:
The objective of this study is to conduct a randomized controlled trial to determine whether the use of the COach2Quit application (app) reduces smoking more than brief advice for smoking cessation. The investigators hypothesize that real time biomarker feedback and messaging support from the COach2Quit app will lead to greater smoking cessation rates than brief anti-smoking advice alone. If effective, the COach2Quit app could be an easily accessible and cost-effective tool to help smokers quit. The findings from this trial could have implications for the delivery of future outpatient smoking cessation programs.
Detailed Description:
The goal of this randomized controlled trial is to assess the efficacy of the novel COach2Quit smartphone application by determining whether the use of this app reduces smoking more than brief anti-smoking advice alone. This will be a two-arm individually randomized trial and participants who are currently smoking will be assigned 1:1 to either study arm. Smoking behavior will be measured through self-report at baseline, 2-week and 1-month follow up visits. Smoking behavior will also be verified by 2 biomarker measurements: carbon monoxide breath test and urine cotinine, collected at baseline, 2-week and 1-month follow-up visits. In addition, participants will receive weekly follow-up calls. The primary outcome will be smoking cessation at the 1-month follow-up visit.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: