Smoking ReductionNCT04133064

Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study

A study testing Pivot Breath Sensor in people with Smoking Reduction and Smoking Behaviors, run by Jennifer Marler, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Smoking Reduction, Smoking Behaviors, Smoking, Tobacco
What is being tested?: Pivot Breath Sensor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 1 siteUnited States
Study dates: 25 Sep 2019to 1 Oct 2020
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 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18-80 years of age
Current daily cigarette smokers (at least 10 cigarettes per day)
Resident of the United States
Able to read and comprehend English
Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 11 and above, or, Android 5.0 and above with operating system Android 5.0 and above)
Willing to sign the Informed Consent Form

Who cannot join

Pregnancy
Participation in a previous study sponsored by Carrot Inc

Trial locations and contacts

1 site in 1 country.

United States1 site

Carrot Inc.
Redwood City, California, 94063

Other trials in United States

About this study

Official title: Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.

Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Read the detailed description

Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor):

Change in attitudes towards quitting smoking
Change in smoking behavior
Participant feedback

Conditions: Smoking Reduction, Smoking Behaviors, Smoking, Tobacco, Smoking Cessation
Being tested: Pivot Breath Sensor
Medical subject headings: Smoking Reduction, Smoking, Tobacco Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pivot Breath SensorDevice
The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.

Study groups in NCT04133064
Study group	Role	What they receive
Pivot Breath Sensor (user group)	Other	Self-reported daily smokers of 10 or more cigarettes per day Receives: Device: Pivot Breath Sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Different Stages of Change in Desire to Quit Smoking
Assessment of participant's desire to quit by measuring Stage of Change.
The participant will be asked if they are serious about quitting smoking and they can select from the following options:
- Yes, within the next 30 days
- Yes, within the next 6 months
- No, not thinking of quitting All data obtained via questionnaires completed by the participants. Throughout the course of the study, if the participant moves from "No, not thinking of quitting" to "yes, within the next 6 months" to "Yes, within the next 30 days" - that is a positive outcome for the participant. If they answered in the reverse, that would be a negative outcome for the participant. In short, becoming more ready to quit is a positive outcome, becoming less ready to quit is a less positive outcome.
Measured: 3 months (12 weeks) compared to baseline
Success to Quit (STQ)
Assessment of participant's attitudes towards quitting by measuring Success to Quit.
The participant will be asked If you were to quit smoking right now, how successful would you be? Rating Scale: 1 = Not at all successful, 10 = Completely successful. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking.
Measured: 3 months (12 weeks)
Difficulty to Quit (DTQ)
Assessment of participant's attitudes towards quitting by measuring Perceived Difficulty to staying Quit.
Participant will be asked: If you were to quit smoking right now, how difficult do you think it would be to stay smoke free? Rating scale: 1 = Really hard to stay quit, 10 = Really easy to stay quit. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking, specifically lower perceived difficulty to quit.
Measured: 3 months (12 weeks)
Average Quit Attempts Made Since Using the Pivot Breath Sensor
Assess participant's smoking behavior by measuring Quit attempts. Participant were asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking?
Measured: 3 months (12 weeks)
Change in Cigarettes Per Day (CPD) From Baseline
Assess participant's smoking behavior by measuring CPD. Participant will be asked to enter a number for: How many cigarettes do you now smoke per day, on average? Enter number value.
Measured: 3 months (12 weeks)
Point Prevalence Abstinence (PPA)
Assess participant's smoking behavior by measuring 7-Day and 30-Day PPA. Participant will be asked: In the last 7 days and 30 days have you smoked any cigarettes? Answer choice: Yes/No 7-Day PPA is defined as answering "No" to "In the last 7 days have you smoked any cigarettes?" 30-Day PPA is defined as answering "No" to "In the last 30 days have you smoked any cigarettes?" Data obtained via questionnaires completed by the participants.
Measured: 3 months (12 weeks)

Secondary outcomes (4)

Feedback on Breath Sensor Setup, Experience and Use
Gather participant feedback on breath sensor setup:
Participant is asked:
1. How would you rate the ease or difficulty of getting started with the breath sensor?
2. How would you rate the ease or difficulty of following the directions on the breath sensor screen?
3. If you ever got an error on the breath sensor screen, how easy or difficult was it to understand the issue and correct it?
Select one:
1. - Very difficult
2. - Difficult
3. - Neither easy nor difficult
4. - Easy
5. - Very Easy I did not set up my breath sensor All data obtained via questionnaires completed by the participants.
Measured: 1 week
Feedback on Impact on Motivation to Quit Smoking
Gather participant feedback on impact of breath sensor:
Participant will be asked: How has using the breath sensor affected your motivation to quit smoking?
Select one:
- Using the breath sensor has increased my motivation to quit smoking
- Using the breath sensor has not affected my motivation to quit smoking
- Using the breath sensor has decreased my motivation to quit smoking
- I haven't used the breath sensor
Measured: 1 week
Feedback on Impact on Number of Cigarettes Smoked Per Day
Gather participant feedback on impact of breath sensor:
Participant will be asked: How has using the breath sensor affected the number of cigarettes you smoke per day?
Select one:
- Using the breath sensor has increased the number of cigarettes I smoke per day
- Using the breath sensor has not affected the number of cigarettes I smoke per day
- Using the breath sensor has decreased the number of cigarettes I smoke per day
- I haven't used the breath sensor
Measured: 1 week
Feedback on Commercialization
Gather participant feedback on commercialization:
Participant will be asked: Hypothetical: if it was commercially available, would you be interested in buying the Pivot Breath Sensor? Answer: Yes/No
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 20191 Oct 2020

First posted21 Oct 2019
Study start25 Sep 2019
Primary completion10 Mar 2020
Study completion1 Oct 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Smoking ReductionStudies of the same condition, open and under way.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04133064
Sponsor's protocol ID: c-202
Status last verified: Oct 2022
First submitted: 9 Oct 2019
Last updated: 9 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Marler JD, Fujii CA, Wong KS, Galanko JA, Balbierz DJ, Utley DS. Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study. J Med Internet Res. 2020 Oct 2;22(10):e22811. doi: 10.2196/22811.
PubMed 32894829

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Communicating About Nicotine Reduction in Cigarettes
Tobacco Products, Smoking Behavior
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
Smoking, Tobacco
Enrolling by invitation
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All Smoking Reduction trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.
ClinicalTrials.gov ID: NCT04133064
Acronym / sponsor ID: c-202
Conditions: Smoking Reduction, Smoking Behaviors, Smoking, Tobacco, Smoking Cessation
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Jennifer Marler, MDIndustry (pharma, biotech, devices)
Study start: 25 Sep 2019 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 1 Oct 2020 (actual)
First posted: 21 Oct 2019 (actual)
Results: Posted 9 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Detailed description

Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor):

Change in attitudes towards quitting smoking
Change in smoking behavior
Participant feedback

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pivot Breath Sensor (user group)	Other	Device: Pivot Breath SensorSelf-reported daily smokers of 10 or more cigarettes per day

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18-80 years of age
Current daily cigarette smokers (at least 10 cigarettes per day)
Resident of the United States
Able to read and comprehend English
Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 11 and above, or, Android 5.0 and above with operating system Android 5.0 and above)

Key exclusion criteria (2 listed)

Pregnancy
Participation in a previous study sponsored by Carrot Inc

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
Pivot Breath SensorThe Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.	Device	Pivot Breath Sensor (user group)

Primary outcome

Number of Participants With Different Stages of Change in Desire to Quit Smoking
Time frame: 3 months (12 weeks) compared to baseline
Assessment of participant's desire to quit by measuring Stage of Change. The participant will be asked if they are serious about quitting smoking and they can select from the following options: * Yes, within the next 30 days * Yes, within the next 6 months * No, not thinking of quitting All data obtained via questionnaires completed by the participants. Throughout the course of the study, if the participant moves from "No, not thinking of quitting" to "yes, within the next 6 months" to "Yes, within the next 30 days" - that is a positive outcome for the participant. If they answered in the reverse, that would be a negative outcome for the participant. In short, becoming more ready to quit is a positive outcome, becoming less ready to quit is a less positive outcome.
Success to Quit (STQ)
Time frame: 3 months (12 weeks)
Assessment of participant's attitudes towards quitting by measuring Success to Quit. The participant will be asked If you were to quit smoking right now, how successful would you be? Rating Scale: 1 = Not at all successful, 10 = Completely successful. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking.
Difficulty to Quit (DTQ)
Time frame: 3 months (12 weeks)
Assessment of participant's attitudes towards quitting by measuring Perceived Difficulty to staying Quit. Participant will be asked: If you were to quit smoking right now, how difficult do you think it would be to stay smoke free? Rating scale: 1 = Really hard to stay quit, 10 = Really easy to stay quit. Higher score is a better outcome for participants, it indicates a more positive attitude towards quitting smoking, specifically lower perceived difficulty to quit.
Average Quit Attempts Made Since Using the Pivot Breath Sensor
Time frame: 3 months (12 weeks)
Assess participant's smoking behavior by measuring Quit attempts. Participant were asked: Since you began using the Pivot Breath Sensor, how many times have you tried to quit smoking?
Change in Cigarettes Per Day (CPD) From Baseline
Time frame: 3 months (12 weeks)
Assess participant's smoking behavior by measuring CPD. Participant will be asked to enter a number for: How many cigarettes do you now smoke per day, on average? Enter number value.
Point Prevalence Abstinence (PPA)
Time frame: 3 months (12 weeks)
Assess participant's smoking behavior by measuring 7-Day and 30-Day PPA. Participant will be asked: In the last 7 days and 30 days have you smoked any cigarettes? Answer choice: Yes/No 7-Day PPA is defined as answering "No" to "In the last 7 days have you smoked any cigarettes?" 30-Day PPA is defined as answering "No" to "In the last 30 days have you smoked any cigarettes?" Data obtained via questionnaires completed by the participants.

4 secondary outcomes

Feedback on Breath Sensor Setup, Experience and Use
Time frame: 1 week
Feedback on Impact on Motivation to Quit Smoking
Time frame: 1 week
Feedback on Impact on Number of Cigarettes Smoked Per Day
Time frame: 1 week
Feedback on Commercialization
Time frame: 4 weeks

Results and safety

Results posted to the registry on 9 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pivot Breath Sensor (User Group)	234	215

Primary outcome: Number of Participants With Different Stages of Change in Desire to Quit Smoking

Time frame: 3 months (12 weeks) compared to baseline. Count of participants. Unit: Participants

Measure	Pivot Breath Sensor (User Group) n = 215
Increased motivation to quit	84
Unchanged motivation to quit	118
Decreased motivation to quit	13

Population analysed: Participants that completed the 12-week questionnaire

Primary outcome: Success to Quit (STQ)

Time frame: 3 months (12 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Pivot Breath Sensor (User Group) n = 215
Value	5 (3.1)

Population analysed: Participants that completed the 12 week questionnaire

Primary outcome: Difficulty to Quit (DTQ)

Time frame: 3 months (12 weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Pivot Breath Sensor (User Group) n = 215
Value	4.3 (3.0)

Population analysed: Participants that completed the 12 week questionnaire

Primary outcome: Average Quit Attempts Made Since Using the Pivot Breath Sensor

Time frame: 3 months (12 weeks). Mean (Standard Deviation). Unit: quit attempts made

Measure	Pivot Breath Sensor (User Group) n = 215
Value	2.4 (9.1)

Population analysed: Participants that completed the 12 week questionnaire

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed for over 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pivot Breath Sensor (User Group)	0 of 234 (0%)	0 of 234 (0%)	0 of 234

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32894829Marler JD, Fujii CA, Wong KS, Galanko JA, Balbierz DJ, Utley DS. Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study. J Med Internet Res. 2020 Oct 2;22(10):e22811. doi: 10.2196/22811.

Related trials for Smoking Reduction

Recruiting
Communicating About Nicotine Reduction in Cigarettes
Tobacco Products, Smoking Behavior
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
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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.

Jen Marler principal investigator

Pivot Health Technologies Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pivot Breath Sensor in people with Smoking Reduction and Smoking Behaviors, run by Jennifer Marler, MD 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 6 inclusion and 2 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 9 Nov 2022. 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 9 Nov 2022). 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?

Number of Participants With Different Stages of Change in Desire to Quit Smoking (time frame: 3 months (12 weeks) compared to baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133064, which also lists 1 linked publication.

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 9 Nov 2022.