COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)

Johns Hopkins University

Status: Completed

Conditions: Smoking; Smoking Cessation

Treatments: Device: Individualized carbon monoxide (iCO) monitor; Behavioral: Cessation counseling; Other: COach2Quit smartphone application

Study type: Interventional

Funder types: Other

Identifiers

NCT03142932

IRB00124820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Control

Active Comparator group

Description:

A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.

Treatment:

Behavioral: Cessation counseling

COach2Quit

Experimental group

Description:

A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model. Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.

Treatment:

Behavioral: Cessation counseling

Other: COach2Quit smartphone application

Device: Individualized carbon monoxide (iCO) monitor