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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.

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 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
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

Other trials in United States

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.

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 groups in NCT05642598
Study groupRoleWhat they receive
Pivot for VapeExperimentalA 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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)

  11. 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

  12. 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)

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

  25. 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)

  26. 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)

  27. 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)

  28. 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)

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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.

  1. First posted8 Dec 2022
  2. Study start7 Feb 2023
  3. Primary completion23 May 2024
  4. Study completion23 May 2024

Resources

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)
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

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.

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