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Study of a Smartphone-Based Switch Program

NCT06544772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

DEVICE

Pivot cigarette smoking cessation program

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.

Sponsors & Collaborators

  • Pivot Health Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Marler, MD · Pivot Health Technologies Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2025-03-05
Completion
2025-06-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06544772 on ClinicalTrials.gov