Clinical trial NCT06544772: Study of a Smartphone-Based Switch Program
Official title: Pilot Study of a Smartphone-Based Program in Adults to Measure Switch Rates From Cigarettes to Smoke-free Nicotine Products (C-520)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
cigarette cessation
digital health
mobile apps
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
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 120 participants to evaluate the Pivot cigarette smoking cessation program in adult smokers, previously unable to quit, who also use other smoke-free nicotine product(s) (poly-use) and wish to stop cigarette smoking by switching to these smoke-free nicotine products.

Detailed description: This is a prospective, open label, single center clinical study conducted with Institutional Review Board approval enrolling up to 120 adult participants who report cigarette smoking and concurrent use of smoke-free nicotine product(s), and wish to switch completely off cigarettes. The study will be performed remotely on an ambulatory basis.

Participants will be asked to set up and use the Pivot cigarette smoking cessation program which comprises a mobile personal breath carbon monoxide sensor (Pivot Breath Sensor) and a smartphone app (Pivot app) with in-app asynchronous text-based coaching with a certified human tobacco cessation coach. The study duration is 26 weeks, with main outcomes assessed at 12 weeks (primary endpoint) and 26 weeks. Participants will receive online questionnaires at intervals throughout the study. Participants who indicate abstinence from cigarette smoking at 12 weeks will be invited to do a video call biovalidation visit in which they perform an observed breath sample using their Pivot breath sensor.

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 program among adult smokers who also use other smoke-free nicotine products, with a focus on assessing trial feasibility, program acceptability, use and engagement, changes in attitudes towards switching from cigarettes to smoke-free nicotine products and changes in cigarette, nicotine product use, and carbon monoxide (CO) values over the course of the 26-week study, as well as participant feedback on the set-up, design, use experience, and impact of the program.

Eligibility criteria: Inclusion Criteria:

* 21-65 years of age
* Smoke ≥ 5 CPD on ≥ 5 days per week
* Have smoked cigarettes for ≥ the last 6 months
* Current use of ≥1 reduced risk smoke-free nicotine product which includes e-cigarettes/vaping, oral nicotine pouch (ONP; ex. Zyn, On, Velo), or heat-not-burn (ex. IQOS, Glo, Ploom, Pulze)
* Planning to quit cigarette smoking by switching to a reduced risk smoke-free nicotine product
* Self-report of ≥ 1 past failed cigarette smoking quit attempt
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smartphone compatible with the study app (iPhone 6 and above with operating system iOS 15 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

Exclusion Criteria:

* Pregnant or breast-feeding (self-report)
* Use of other smoking cessation apps, coaching, classes, or quit programs at entry or within previous 30 days
* Current use of nicotine replacement therapy (NRT), chewing tobacco or cigars
* Smokes marijuana ≥ 4 days per week
* Current enrollment in another clinical trial
* 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: Proportion of participants who completely switch from cigarettes to a smoke-free nicotine product by 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Trial feasibility: online screening form completers
timeFrame: Enrollment
measure: Trial feasibility: eligible online screening form completers
timeFrame: Enrollment
measure: Trial feasibility: study enrollment
timeFrame: Enrollment
measure: Trial feasibility: Study completion
timeFrame: 12 and 26 weeks
measure: Engagement with program - app openings/sessions
timeFrame: 12 weeks
measure: Engagement with program - number of days with app openings/sessions
timeFrame: 12 weeks
measure: Engagement with program - number of weeks with app openings/sessions
timeFrame: 12 weeks
measure: Engagement with program - average duration of app sessions
timeFrame: 12 weeks
measure: Engagement with program - use of app features
timeFrame: 12 weeks
measure: Engagement with coaching
timeFrame: 12 weeks
measure: Average number of weeks with coaching engagement
timeFrame: 12 weeks
measure: User satisfaction - Net Promoter Score
timeFrame: 4, 12 and 26 weeks
measure: User feedback - setting up and getting started with the program
timeFrame: 1 week
measure: Participant need for the program
timeFrame: 4 weeks
measure: User satisfaction - helpful for switching
timeFrame: 8 weeks
measure: Change in Self-Efficacy
timeFrame: 6, 12 and 26 weeks
measure: Change in Expected Difficulty in Staying Switched
timeFrame: 4, 8 and 12 weeks
measure: Change in Confidence Levels Towards Switching
timeFrame: 4, 8 and 12 weeks
measure: Desire to Switch (Yes/No)
timeFrame: 4 weeks
measure: Interest in Switching
timeFrame: Baseline
measure: Self-Reported Switch
timeFrame: 12 and 26 weeks
measure: Biochemically Confirmed Abstinence
timeFrame: 12 weeks
measure: Self-Reported Continuous Maintenance of Switch
timeFrame: 26 weeks
measure: Duration of Self-Reported Switch
timeFrame: 12 and 26 weeks
measure: Duration of Abstinence from Cigarettes
timeFrame: 12 and 26 weeks
measure: Self-Reported Use/Abstinence of Other Nicotine-Containing Products
timeFrame: 12 and 26 weeks
measure: Duration of Self-Reported Abstinence from All Nicotine Products
timeFrame: 12 and 26 weeks
measure: Proportion with ≥ 50% CPD Reduction
timeFrame: 12 and 26 weeks
measure: Average % CPD Reduction
timeFrame: 12 and 26 weeks
measure: Change in CPD
timeFrame: 12 and 26 weeks
measure: Change in Nicotine Product Use
timeFrame: 12 and 26 weeks
measure: Attempts to Switch
timeFrame: 4, 8, 12 and 26 weeks
measure: Attempts to Quit Nicotine Products
timeFrame: 8, 12 and 26 weeks
measure: Change in breath CO values for frequent breath sensor users
timeFrame: 1, 4, 8 and 12 weeks
measure: Change in breath CO values on Saturdays
timeFrame: 1-12 weeks
measure: Change in participant self-reported health
timeFrame: 26 weeks
measure: Use of other smoking cessation tools
timeFrame: 12 and 26 weeks
measure: Change in Alcohol Use Behavior
timeFrame: 12 and 26 weeks
measure: Change in presence of depressive symptoms
timeFrame: 12 and 26 weeks
measure: Living environment relating to nicotine product use and cigarette smoking
timeFrame: 12 and 26 weeks
measure: Living/relationship environment relating to nicotine product use and cigarette smoking
timeFrame: 12 and 26 weeks
measure: Social environment relating to nicotine product use and cigarette smoking
timeFrame: 12 and 26 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: