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

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ClinicalTrials.gov Identifier: NCT03142932
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Maryland Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Device: Individualized carbon monoxide (iCO) monitor Other: COach2Quit smartphone application Behavioral: Cessation counseling Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.
Behavioral: Cessation counseling
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.

Experimental: COach2Quit

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.

Device: Individualized carbon monoxide (iCO) monitor
a personal monitor for a breath test for carbon monoxide (CO)

Other: COach2Quit smartphone application
This smartphone application works in conjunction with the iCO monitor

Behavioral: Cessation counseling
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.




Primary Outcome Measures :
  1. 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.

  2. Smoking status using a point of care 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.


Secondary Outcome Measures :
  1. Smoking status using a point of care test for measuring carbon monoxide (CO) [ Time Frame: 2 weeks ]
    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.

  2. Smoking status using a point of care test for measuring cotinine [ Time Frame: 2 weeks ]
    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.

  3. Urge to smoke using a questionnaire of smoking urges [ Time Frame: 2 weeks ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  4. Urge to smoke using a questionnaire of smoking urges [ Time Frame: 1 month ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  5. Withdrawal symptoms using a questionnaire based on Wisconsin Smoking Withdrawal Scale [ Time Frame: 2 weeks ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  6. Withdrawal symptoms using a questionnaire based on Wisconsin Smoking Withdrawal Scale [ Time Frame: 1 month ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  7. Reinforcing Smoking Decisional Balance using a questionnaire [ Time Frame: 2 weeks ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  8. Reinforcing Smoking Decisional Balance using a questionnaire [ Time Frame: 1 month ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  9. Smoking Abstinence Self-Efficacy using Self-Efficacy/Temptation Scale Long Form (used by Shuter) [ Time Frame: 2 weeks ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  10. Smoking Abstinence Self-Efficacy using Self-Efficacy/Temptation Scale Long Form (used by Shuter) [ Time Frame: 1 month ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  11. Nicotine dependence using Fagerstrom test [ Time Frame: 2 weeks ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  12. Nicotine dependence using Fagerstrom test [ Time Frame: 1 month ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  13. Satisfaction with the program using brief questionnaire [ Time Frame: 2 weeks ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable

  14. Satisfaction with the program using brief questionnaire [ Time Frame: 1 month ]
    Although formal analysis is precluded by the moderate sample size in this pilot investigation, we will examine how treatments affect this intermediate variable



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142932


Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
Maryland Department of Health and Mental Hygiene
Investigators
Principal Investigator: Jonathan E Golub, PhD Johns Hopkins University

Additional Information:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03142932     History of Changes
Other Study ID Numbers: IRB00124820
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Johns Hopkins University:
smoking

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs