SmokingC2QNCT03142932
COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
A study testing Individualized carbon monoxide (iCO) monitor, COach2Quit smartphone application and Cessation counseling in people with Smoking and Smoking Cessation, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Individualized carbon monoxide (iCO) monitor, COach2Quit smartphone application and Cessation counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21231
About this study
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.
Read the 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.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Individualized carbon monoxide (iCO) monitor, COach2Quit smartphone application, Cessation counseling
- Keywords
- smoking
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized carbon monoxide (iCO) monitorDevice
a personal monitor for a breath test for carbon monoxide (CO)
COach2Quit smartphone applicationOther
This smartphone application works in conjunction with the iCO monitor
Cessation counselingBehavioural
The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model. Receives: Behavioral: Cessation counseling |
| COach2Quit | Experimental | 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. Receives: Device: Individualized carbon monoxide (iCO) monitor; Other: COach2Quit smartphone application; Behavioral: Cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.
Measured: baseline
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.
Measured: 1 month
Number of Participants With Color Change for Urine Test for Measuring Cotinine
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.
Measured: baseline
Number of Participants With Color Change for Urine Test for Measuring Cotinine
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.
Measured: 1 month
Secondary outcomes (1)
Reasons for Quitting Scale
We used the Reasons for Quitting (RFQ) scale to measure motivation to quit smoking. The scale is used to measure intrinsic and extrinsic motivation for quitting smoking. Each item in the scale is evaluated using a 5-point Likert scale regarding how true the statement is about the participant's motivation to quit smoking (Not at all true, a little bit true, moderately true, quite true, extremely true). Each option takes on a numerical score from 0 (not at all true) to 4 (extremely true). Scores are summed across all items in the scale and divided by the number of items in the scale to obtain the RFQ score. The range of possible scores is 0 to 4. A higher score indicates greater motivation to quit smoking.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start17 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene
- Responsible party
- Sponsor
- Investigators
- Jonathan E Golub, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142932
- Sponsor's protocol ID
- IRB00124820
- Acronym
- C2Q
- Status last verified
- Oct 2019
- First submitted
- 28 Apr 2017
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03142932
- Acronym / sponsor ID
- C2Q / IRB00124820
- Conditions
- Smoking, Smoking Cessation
- Keywords
- smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene
- Study start
- 17 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Posted 1 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Cessation counselingA certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model. |
| COach2Quit | Experimental | Device: Individualized carbon monoxide (iCO) monitor, Other: COach2Quit smartphone application, Behavioral: Cessation counselingA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized carbon monoxide (iCO) monitora personal monitor for a breath test for carbon monoxide (CO) | Device | COach2Quit |
| COach2Quit smartphone applicationThis smartphone application works in conjunction with the iCO monitor | Other | COach2Quit |
| Cessation counselingThe advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up. | Behavioural | COach2Quit, Control |
Primary outcome
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
Time frame: baseline
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
Time frame: 1 month
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Time frame: baseline
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.
Number of Participants With Color Change for Urine Test for Measuring Cotinine
Time frame: 1 month
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.
1 secondary outcome
Reasons for Quitting Scale
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan E Golub, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized carbon monoxide (iCO) monitor, COach2Quit smartphone application and Cessation counseling in people with Smoking and Smoking Cessation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.