Clinical trial NCT05642598: Pilot Study of a Smartphone-Based Vaping Cessation Program
Official title: Pilot Study of a Smartphone-Based Vaping Cessation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping Cessation
Keywords: vaping cessation
e-cigarette cessation
digital health
mobile apps
health promotion
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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)

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Vaping cessation rate: 30-day PPA
timeFrame: 6 months (26 weeks)
Secondary outcomes:
measure: Change in expected difficulty in staying quit
timeFrame: 6 months (26 weeks)
measure: Change in confidence levels toward quitting vaping (expected success in quitting)
timeFrame: 6 months (26 weeks)
measure: Desire to quit vaping
timeFrame: 4 weeks
measure: Vaping cessation rate: 7-day PPA
timeFrame: 6 months (26 weeks)
measure: Self-reported continuous abstinence at 26 weeks
timeFrame: 6 months (26 weeks)
measure: Self-reported continuous abstinence at 52 weeks
timeFrame: 1 year (52 weeks)
measure: Self-reported serial abstinence
timeFrame: 1 year (52 weeks)
measure: Self-reported abstinence from all tobacco products
timeFrame: 6 months (26 weeks)
measure: The proportion of participants who reduced their vaping sessions per day (VSPD) by ≥ 50% compared to baseline
timeFrame: 6, 12, 26, and 52 weeks
measure: Percent change in vape sessions per day (VSPD) compared to baseline
timeFrame: 6 months (26 weeks)
measure: The proportion of participants who reduced the amount of vape juice / e-liquid consumed by ≥ 50% compared to baseline
timeFrame: 6, 12, 26, and 52 weeks
measure: Percent change in the amount of vape juice / e-liquid consumed compared to baseline
timeFrame: 6 months (26 weeks)
measure: The proportion of participants who reduced their vape juice / e-liquid nicotine concentration by ≥ 50% compared to baseline
timeFrame: 6, 12, 26, and 52 weeks
measure: The proportion of participants who report decreased/unchanged/increased vaping compared to baseline
timeFrame: 6, 12, 26, and 52 weeks
measure: Number of quit attempts
timeFrame: 4, 12, 26, and 52 weeks
measure: Change in vaping / e-cig dependence
timeFrame: 12, 26, and 52 weeks
measure: User feedback - starting the vaping cessation program
timeFrame: 2 weeks
measure: User satisfaction - Net Promoter Score
timeFrame: 4, 12, and 26 weeks
measure: User satisfaction - helpful for quitting
timeFrame: 8 and 12 weeks
measure: Engagement with program - app openings
timeFrame: 6 months (26 weeks)
measure: Engagement with program - number of days with app openings
timeFrame: 6 months (26 weeks)
measure: Engagement with program - number of weeks with app openings
timeFrame: 6 months (26 weeks)
measure: Engagement with program - average duration of app sessions
timeFrame: 6 months (26 weeks)
measure: Engagement with program - use of app features
timeFrame: 6 months (26 weeks)
measure: Engagement with coach
timeFrame: 6 months (26 weeks)
measure: Average number of weeks with coach engagement
timeFrame: 6 months (26 weeks)
measure: Change in participant self-reported health
timeFrame: 6 months (26 weeks)
measure: Use of other vaping cessation tools
timeFrame: 6 months (26 weeks)
measure: Alcohol use behavior
timeFrame: 12, 26, and 52 weeks
measure: Presence of depressive symptoms
timeFrame: 12, 26, and 52 weeks
measure: Living environment relating to vaping and cigarette smoking
timeFrame: 12, 26, and 52 weeks
measure: Living/relationship environment relating to vaping and cigarette smoking
timeFrame: 12, 26, and 52 weeks
measure: Social environment relating to vaping and cigarette smoking
timeFrame: 12, 26, and 52 weeks
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: Pivot Health Technologies, Inc.
state: California
Study officials:
affiliation: Pivot Health Technologies Inc.
name: Jennifer Marler, MD
role: PRINCIPAL_INVESTIGATOR
References: