Vaping CessationNCT05642598
Pilot Study of a Smartphone-Based Vaping Cessation Program
A study testing Pivot for Vape in people with Vaping Cessation, run by Pivot Health Technologies Inc. at 1 site in United States.
Trial summary
Prospective, open label, single center clinical study enrolling up to 100 participants to evaluate the effect of the Pivot vaping cessation program. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaping Cessation
- What is being tested?
- Pivot for Vape
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to 23 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current daily nicotine vape/e-cigarette user for at least the past 30 days
- Plans to quit vaping in the next 6 months
- Reports average VSPD ≥ 5
- Interested in working with a vape cessation coach via SMS text
- Resident of the United States
- Able to read and comprehend English
Show all 10Show fewer
- Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 12 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
- Has daily internet access on smartphone
- Comfortable downloading and using smartphone apps
- Willing to sign the Informed Consent Form (ICF)
Who cannot join
- Using other vaping cessation apps, coaching, classes, or quit programs at entry
- Currently using cigarettes
- If previous cigarette smoker, need to have quit smoking at least 3 months ago (self-report)
- Failure to provide contact or collateral information, and/or failure to verify email address
- Participation in a previous study sponsored by Pivot Health Technologies Inc. (formerly Carrot Inc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pivot Health Technologies, Inc.
San Carlos, California, 94070
About this study
Prospective, open label, single center clinical study enrolling up to 100 participants to evaluate the effect of the Pivot vaping cessation program.
Read the detailed description
This is a prospective, open label, single center clinical study conducted with IRB approval enrolling up to 100 adult participants who report daily vaping. The study will be performed remotely on an ambulatory basis.
Participants will be asked to set up and use the "Pivot for Vape" program. The program includes an app, moderated online community, and SMS-based coaching with a tobacco treatment specialist. The study duration is 52 weeks, with the estimated active time using the program of up to 6 months and the time thereafter as follow-up. Participants will receive online questionnaires at intervals throughout the study.
Potential participants will complete an online screening form. Eligible participants will be called to confirm eligibility, discuss the study, and have their questions about the study answered. Interested eligible participants will complete the electronic informed consent form and baseline questionnaire prior to downloading the app on their smartphone.
The investigators aim to assess the performance of the "Pivot for Vape" program, with a focus on assessing use and engagement, changes in attitudes towards quitting vaping and changes in vaping behavior over the course of the 1-year study, as well as participant feedback on the set-up, design, use experience, and impact of the program.
- Conditions
- Vaping Cessation
- Being tested
- Pivot for Vape
- Keywords
- vaping cessation, e-cigarette cessation, digital health, mobile apps, health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivot for VapeBehavioural
"Pivot for Vape" vaping cessation smartphone app and program
| Study group | Role | What they receive |
|---|---|---|
| Pivot for Vape | Experimental | A commercially available mobile phone app and program for vaping cessation Receives: Behavioral: Pivot for Vape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaping cessation rate: 30-day PPA
30-day point prevalence abstinence (PPA) is defined as a participant self-report of no vaping for the past 30 days
Measured: 6 months (26 weeks)
Secondary outcomes (33)
Change in expected difficulty in staying quit
Participant self report. Difficulty staying quit (DTQ), scale 1-10, higher values indicate greater difficulty staying quit (vape free).
Measured: 6 months (26 weeks)
Change in confidence levels toward quitting vaping (expected success in quitting)
Participant self report. Confidence levels or expected success in quitting (STQ), scale 1-10, higher values indicate greater confidence/greater expected success in quitting.
Measured: 6 months (26 weeks)
Desire to quit vaping
Desire to quit vaping defined as a participant self-report of "yes" to "Would you like to completely stop vaping/using e-cigarettes?". Answer options include "yes" and "no".
Measured: 4 weeks
Vaping cessation rate: 7-day PPA
7-day point-prevalence abstinence (PPA) is defined as a participant self-report of no vaping in the past 7 days.
Measured: 6 months (26 weeks)
Self-reported continuous abstinence at 26 weeks
Defined as a self-report of 7-day (or greater) ppa at 12 weeks, self-report of 30-day ppa at 26 weeks, and no. more than 5 vaping sessions since 12 weeks.
Measured: 6 months (26 weeks)
Self-reported continuous abstinence at 52 weeks
Defined as a self-reported continuous abstinence at 26 weeks and self-report of 30-day ppa at 52 weeks.
Measured: 1 year (52 weeks)
Self-reported serial abstinence
Defined as a self-report of continuous abstinence at 26 weeks, a self-report of 30-day ppa at 52 weeks, and no more than 5 vaping sessions since 26 weeks.
Measured: 1 year (52 weeks)
Self-reported abstinence from all tobacco products
Tobacco product use is self-reported. Participants are asked about the following products: cigars, cigarillos, little filtered cigars, a regular pipe, cigarettes, hookah or water pipe, smokeless tobacco, chew, and snuff
Measured: 6 months (26 weeks)
The proportion of participants who reduced their vaping sessions per day (VSPD) by ≥ 50% compared to baseline
Number of vape session per day (VSPD) are self-reported
Measured: 6, 12, 26, and 52 weeks
Percent change in vape sessions per day (VSPD) compared to baseline
Number of vape session per day (VSPD) are self-reported
Measured: 6 months (26 weeks)
The proportion of participants who reduced the amount of vape juice / e-liquid consumed by ≥ 50% compared to baseline
Vape juice / e-liquid consumption volume is self-reported in mL/day or mL/week
Measured: 6, 12, 26, and 52 weeks
Percent change in the amount of vape juice / e-liquid consumed compared to baseline
Vape juice / e-liquid consumption volume is self-reported in mL/day or mL/week
Measured: 6 months (26 weeks)
The proportion of participants who reduced their vape juice / e-liquid nicotine concentration by ≥ 50% compared to baseline
Nicotine concentration is self-reported in mg/mL
Measured: 6, 12, 26, and 52 weeks
The proportion of participants who report decreased/unchanged/increased vaping compared to baseline
Amount of vaping is quantified as volume/day (mL/day) x concentration of nicotine (mg/mL)
Measured: 6, 12, 26, and 52 weeks
Number of quit attempts
Defined as participant answering ≥1 to the following question: "Since you began the study, how many times have you tried to quit vaping where you've gone at least 1 day without vaping, even a single puff?"
Measured: 4, 12, 26, and 52 weeks
Change in vaping / e-cig dependence
Assessed via the Penn State Electronic Cigarette Dependence Index, 10 items. Possible scores on the index range from 0-20. Scores from 0-3 indicate no dependence, 4-8 low dependence, 9-12 medium dependence, 13+ high dependence
Measured: 12, 26, and 52 weeks
User feedback - starting the vaping cessation program
Specifically regarding set-up and getting started with the program. Participants asked: "How easy or difficult was it to set-up and get started in the Pivot program?". Answered on a range from 1-10; 1 = Very difficult, and 10 = Very easy. A higher score indicates greater ease of program set-up and getting started.
Measured: 2 weeks
User satisfaction - Net Promoter Score
Specifically regarding likelihood to recommend to a friend, Net Promoter Score (NPS). Participants asked: "How likely are you to recommend your study program to a friend or colleague?". Answered on a range from 1-10; 1 = Not at all likely, and 10 = Very likely. A higher score indicates greater user satisfaction and promotion of the program.
Measured: 4, 12, and 26 weeks
User satisfaction - helpful for quitting
Specifically regarding whether the program was useful in helping participants quit vaping. Participants are asked: "Which of the following best describes the Pivot program's ability to help someone quit vaping?". Answer choices include the following: "The program is extremely helpful to quitting vaping"; "The program is helpful to quitting vaping"; "The program does not affect being able to quit vaping"; and "The program makes quitting vaping harder".
Measured: 8 and 12 weeks
Engagement with program - app openings
Collected via back-end app data collection. Engagement is specifically assessed with number of times the Pivot app was opened (number of app openings), number of days the app was opened, and the number of weeks the app was opened.
Measured: 6 months (26 weeks)
Engagement with program - number of days with app openings
Collected via back-end app data collection. Engagement is specifically assessed with the number of days over which the app was opened by participants.
Measured: 6 months (26 weeks)
Engagement with program - number of weeks with app openings
Collected via back-end app data collection. Engagement is specifically assessed with the number of weeks over which the app was opened by participants.
Measured: 6 months (26 weeks)
Engagement with program - average duration of app sessions
Collected via back-end app data collection. Engagement is specifically assessed with the average duration of app sessions completed by participants. Outcome unit of measure = duration in minutes.
Measured: 6 months (26 weeks)
Engagement with program - use of app features
Collected via back-end app data collection. Engagement is specifically assessed with the use of app features (practice quits, challenges, logging vape sessions) by participants. Reported as the number of times each app feature was used.
Measured: 6 months (26 weeks)
Engagement with coach
Collected via back-end app data collection. Engagement is specifically assessed with average number of messages sent by coach to participant per week and average number of messages sent by participant to coach per week.
Measured: 6 months (26 weeks)
Average number of weeks with coach engagement
Collected via back-end app data collection. Specifically, the average number of weeks with at least one message sent from participant to coach.
Measured: 6 months (26 weeks)
Change in participant self-reported health
Participant health is assessed with the following: "Would you say that in general your health is... Select one" And the following choices: "Excellent", "Very good", "Good", "Fair", and "Poor"
Measured: 6 months (26 weeks)
Use of other vaping cessation tools
Assessed via self-report. Participants are asked about other vaping cessation tools they have used throughout the last 6 months. Tools asked about include: apps (other than Pivot), counseling, medications, acupuncture, hypnotherapy, etc. Participants can report other tools not included in the list provided. Outcome reported as the number of participants who have used each other vaping cessation tool.
Measured: 6 months (26 weeks)
Alcohol use behavior
Assessed via the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) screening questionnaire, 3 items. A score is calculated from a sum of the 3 items. Possible scores on the scale range from 0-12. A score of 0 indicates no alcohol use. Higher scores indicate greater alcohol use behavior, a worse outcome.
Measured: 12, 26, and 52 weeks
Presence of depressive symptoms
Assessed via the Center of Epidemiological Studies Depression Scale (CES-D) screening questionnaire, 10 items. A score is calculated from a sum of the 10 items. Possible scores on the scale range from 0-30. Higher scores indicate greater severity of depressive symptoms, a worse outcome.
Measured: 12, 26, and 52 weeks
Living environment relating to vaping and cigarette smoking
Assessed via participant self-report of living with other adults who vape and/or smoke, living with a romantic partner who vapes and/or smokes. Participants asked: "Of the adults you live with, how many smoke cigarettes?" and "Of the adults you live with, how many vape/use e-cigs?". Outcome unit of measure = number of adults.
Measured: 12, 26, and 52 weeks
Living/relationship environment relating to vaping and cigarette smoking
Assessed via participant self-report of living with a romantic partner who vapes and/or smokes. Participants asked: "Do you live with a romantic partner who smokes cigarettes?" (yes/no) and "Do you live with a romantic partner who vapes/uses e-cigs?" (yes/no). Outcomes measure reported as number of participants who live with a romantic partner that smokes, and number that live with a romantic partner that vapes (participants that answer yes to these questions).
Measured: 12, 26, and 52 weeks
Social environment relating to vaping and cigarette smoking
Assessed via participant self-report of the number of their close friends who vape and/or smoke. Participants asked: "How many of your close friends smoke cigarettes?" and "How many of your close friends vape/use e-cigs?". Outcome unit of measure = number of close friends.
Measured: 12, 26, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start7 Feb 2023
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaping CessationStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pivot Health Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jennifer Marler, MD, Pivot Health Technologies Inc.
- Investigators
- Jennifer Marler, MD, Principal investigator, Pivot Health Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642598
- Sponsor's protocol ID
- C-503
- Status last verified
- Jan 2025
- First submitted
- 18 Nov 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Outcomes of a Comprehensive Mobile Vaping Cessation Program in Adults Who Vape Daily: Cohort Study. JMIR Form Res. 2024 Oct 28;8:e57376. doi: 10.2196/57376.
PubMed 39331522
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Smartphone-Based Vaping Cessation Program
- ClinicalTrials.gov ID
- NCT05642598
- Acronym / sponsor ID
- C-503
- Conditions
- Vaping Cessation
- Keywords
- vaping cessation, e-cigarette cessation, digital health, mobile apps, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Pivot Health Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
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 clinical study enrolling up to 100 participants to evaluate the effect of the Pivot vaping cessation program.
Detailed description
This is a prospective, open label, single center clinical study conducted with IRB approval enrolling up to 100 adult participants who report daily vaping. The study will be performed remotely on an ambulatory basis.
Participants will be asked to set up and use the "Pivot for Vape" program. The program includes an app, moderated online community, and SMS-based coaching with a tobacco treatment specialist. The study duration is 52 weeks, with the estimated active time using the program of up to 6 months and the time thereafter as follow-up. Participants will receive online questionnaires at intervals throughout the study.
Potential participants will complete an online screening form. Eligible participants will be called to confirm eligibility, discuss the study, and have their questions about the study answered. Interested eligible participants will complete the electronic informed consent form and baseline questionnaire prior to downloading the app on their smartphone.
The investigators aim to assess the performance of the "Pivot for Vape" program, with a focus on assessing use and engagement, changes in attitudes towards quitting vaping and changes in vaping behavior over the course of the 1-year study, as well as participant feedback on the set-up, design, use experience, and impact of the program.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pivot for Vape | Experimental | Behavioral: Pivot for VapeA commercially available mobile phone app and program for vaping cessation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Current daily nicotine vape/e-cigarette user for at least the past 30 days
- Plans to quit vaping in the next 6 months
- Reports average VSPD ≥ 5
- Interested in working with a vape cessation coach via SMS text
- Resident of the United States
Key exclusion criteria (5 listed)
- Using other vaping cessation apps, coaching, classes, or quit programs at entry
- Currently using cigarettes
- If previous cigarette smoker, need to have quit smoking at least 3 months ago (self-report)
- Failure to provide contact or collateral information, and/or failure to verify email address
- Participation in a previous study sponsored by Pivot Health Technologies Inc. (formerly 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 for Vape"Pivot for Vape" vaping cessation smartphone app and program | Behavioural | Pivot for Vape |
Primary outcome
Vaping cessation rate: 30-day PPA
Time frame: 6 months (26 weeks)
30-day point prevalence abstinence (PPA) is defined as a participant self-report of no vaping for the past 30 days
33 secondary outcomes
Change in expected difficulty in staying quit
Time frame: 6 months (26 weeks)
Change in confidence levels toward quitting vaping (expected success in quitting)
Time frame: 6 months (26 weeks)
Desire to quit vaping
Time frame: 4 weeks
Vaping cessation rate: 7-day PPA
Time frame: 6 months (26 weeks)
Self-reported continuous abstinence at 26 weeks
Time frame: 6 months (26 weeks)
Self-reported continuous abstinence at 52 weeks
Time frame: 1 year (52 weeks)
Self-reported serial abstinence
Time frame: 1 year (52 weeks)
Self-reported abstinence from all tobacco products
Time frame: 6 months (26 weeks)
The proportion of participants who reduced their vaping sessions per day (VSPD) by ≥ 50% compared to baseline
Time frame: 6, 12, 26, and 52 weeks
Percent change in vape sessions per day (VSPD) compared to baseline
Time frame: 6 months (26 weeks)
The proportion of participants who reduced the amount of vape juice / e-liquid consumed by ≥ 50% compared to baseline
Time frame: 6, 12, 26, and 52 weeks
Percent change in the amount of vape juice / e-liquid consumed compared to baseline
Time frame: 6 months (26 weeks)
The proportion of participants who reduced their vape juice / e-liquid nicotine concentration by ≥ 50% compared to baseline
Time frame: 6, 12, 26, and 52 weeks
The proportion of participants who report decreased/unchanged/increased vaping compared to baseline
Time frame: 6, 12, 26, and 52 weeks
Number of quit attempts
Time frame: 4, 12, 26, and 52 weeks
Change in vaping / e-cig dependence
Time frame: 12, 26, and 52 weeks
User feedback - starting the vaping cessation program
Time frame: 2 weeks
User satisfaction - Net Promoter Score
Time frame: 4, 12, and 26 weeks
User satisfaction - helpful for quitting
Time frame: 8 and 12 weeks
Engagement with program - app openings
Time frame: 6 months (26 weeks)
Engagement with program - number of days with app openings
Time frame: 6 months (26 weeks)
Engagement with program - number of weeks with app openings
Time frame: 6 months (26 weeks)
Engagement with program - average duration of app sessions
Time frame: 6 months (26 weeks)
Engagement with program - use of app features
Time frame: 6 months (26 weeks)
Engagement with coach
Time frame: 6 months (26 weeks)
Average number of weeks with coach engagement
Time frame: 6 months (26 weeks)
Change in participant self-reported health
Time frame: 6 months (26 weeks)
Use of other vaping cessation tools
Time frame: 6 months (26 weeks)
Alcohol use behavior
Time frame: 12, 26, and 52 weeks
Presence of depressive symptoms
Time frame: 12, 26, and 52 weeks
Living environment relating to vaping and cigarette smoking
Time frame: 12, 26, and 52 weeks
Living/relationship environment relating to vaping and cigarette smoking
Time frame: 12, 26, and 52 weeks
Social environment relating to vaping and cigarette smoking
Time frame: 12, 26, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 39331522Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Outcomes of a Comprehensive Mobile Vaping Cessation Program in Adults Who Vape Daily: Cohort Study. JMIR Form Res. 2024 Oct 28;8:e57376. doi: 10.2196/57376.
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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.
Jennifer Marler, MD 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 for Vape in people with Vaping Cessation, run by Pivot Health Technologies Inc. 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 10 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 31 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vaping cessation rate: 30-day PPA (time frame: 6 months (26 weeks)). 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 NCT05642598, 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 31 Jan 2025.