Smoking Cessation Clinical Trial
— C2QOfficial title:
COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
Verified date | October 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Maryland Department of Health and Mental Hygiene |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline | |
Primary | 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. | 1 month | |
Primary | 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. | baseline | |
Primary | 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. | 1 month | |
Secondary | 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. | baseline |
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