Status:
COMPLETED
Study of a Smartphone-Based Switch Program
Lead Sponsor:
Pivot Health Technologies Inc.
Conditions:
Smoking Cessation
Eligibility:
All Genders
21-65 years
Phase:
NA
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 u...
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 us...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06544772
Start Date
August 16 2024
End Date
June 9 2025
Last Update
October 2 2025
Active Locations (1)
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1
Pivot Health Technologies, Inc.
San Carlos, California, United States, 94070