Study of a Smartphone-Based Switch Program

NCT06544772 | Completed FDA Device

• 1 other identifier: C-520
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking cessation; cigarette cessation; digital health; mobile apps

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who completely switch from cigarettes to a smoke-free nicotine product by 12 weeks

  The proportion of participants who self-report 7-day point prevalence abstinence (PPA) from cigarettes at 12 weeks and self-report the use of 1 or more smoke-free nicotine products at 12 weeks.

  12 weeks

Secondary Outcomes (42)

• Trial feasibility: online screening form completers

  Enrollment

• Trial feasibility: eligible online screening form completers

  Enrollment

• Trial feasibility: study enrollment

  Enrollment

• Trial feasibility: Study completion

  12 and 26 weeks

• Engagement with program - app openings/sessions

  12 weeks

Study Arms (1)

Pivot cigarette smoking cessation program

EXPERIMENTAL

A commercially available mobile phone app and program for smoking cessation

Device: Pivot cigarette smoking cessation program

Interventions

Pivot cigarette smoking cessation program DEVICE

The Pivot cigarette smoking cessation program comprises a mobile personal breath carbon monoxide sensor (Pivot Breath Sensor) and a smartphone app (Pivot app) with in-app asynchronous SMS text-based coaching with a certified human tobacco cessation coach.

Pivot cigarette smoking cessation program

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Pivot Health Technologies Inc.: lead

Study Sites (1)

Pivot Health Technologies, Inc.

San Carlos, California, 94070, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Jennifer Marler, MD

  Pivot Health Technologies Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Research Associate

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 16, 2024
• Primary Completion: March 5, 2025
• Study Completion: June 9, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)