Clinical trial NCT03142932: COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
Official title: COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: smoking
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Maryland Department of Health and Mental Hygiene
First posted: 2017-05-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* current, daily smokers
* agree to participate and anticipate to be living in Baltimore for at least 2 months
* own a phone that is compatible with the app
* be willing to set at baseline assessment a quit date within 2 weeks

Exclusion Criteria:

* are suffering from any unstable medical condition precluding the use of the CO monitor (e.g. severe COPD)
* are currently using smokeless tobacco including e-cigarettes
* are currently using nicotine replacement therapy or other smoking cessation treatment
* are pregnant, determined by participant self-report
* have a negative baseline result on both urine cotinine AND CO monitor

Primary outcomes:
measure: Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
timeFrame: baseline
measure: Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
timeFrame: 1 month
measure: Number of Participants With Color Change for Urine Test for Measuring Cotinine
timeFrame: baseline
measure: Number of Participants With Color Change for Urine Test for Measuring Cotinine
timeFrame: 1 month
Secondary outcomes:
measure: Reasons for Quitting Scale
timeFrame: baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jonathan E Golub, PhD
role: PRINCIPAL_INVESTIGATOR
References: