Study of a Smartphone-Based Switch Program

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.

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.)