NCT05642598

Brief Summary

Prospective, open label, single center clinical study enrolling up to 100 participants to evaluate the effect of the Pivot vaping cessation program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2024

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

November 18, 2022

Last Update Submit

January 29, 2025

Conditions

Vaping Cessation

Keywords

vaping cessatione-cigarette cessationdigital healthmobile appshealth promotion

Outcome Measures

Primary Outcomes (1)

  • Vaping cessation rate: 30-day PPA

    30-day point prevalence abstinence (PPA) is defined as a participant self-report of no vaping for the past 30 days

    6 months (26 weeks)

Secondary Outcomes (33)

  • Change in expected difficulty in staying quit

    6 months (26 weeks)

  • Change in confidence levels toward quitting vaping (expected success in quitting)

    6 months (26 weeks)

  • Desire to quit vaping

    4 weeks

  • Vaping cessation rate: 7-day PPA

    6 months (26 weeks)

  • Self-reported continuous abstinence at 26 weeks

    6 months (26 weeks)

  • +28 more secondary outcomes

Study Arms (1)

Pivot for Vape

EXPERIMENTAL

A commercially available mobile phone app and program for vaping cessation

Behavioral: Pivot for Vape

Interventions

Pivot for VapeBEHAVIORAL

"Pivot for Vape" vaping cessation smartphone app and program

Pivot for Vape

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current daily nicotine vape/e-cigarette user for at least the past 30 days
  • Plans to quit vaping in the next 6 months
  • Reports average VSPD ≥ 5
  • Interested in working with a vape cessation coach via SMS text
  • Resident of the United States
  • Able to read and comprehend English
  • Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 12 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 (ICF)

You may not qualify if:

  • Using other vaping cessation apps, coaching, classes, or quit programs at entry
  • Currently using cigarettes
  • If previous cigarette smoker, need to have quit smoking at least 3 months ago (self-report)
  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pivot Health Technologies, Inc.

San Carlos, California, 94070, United States

Location

Related Publications (1)

  • Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Outcomes of a Comprehensive Mobile Vaping Cessation Program in Adults Who Vape Daily: Cohort Study. JMIR Form Res. 2024 Oct 28;8:e57376. doi: 10.2196/57376.

    PMID: 39331522DERIVED

MeSH Terms

Interventions

Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

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
VP of Clinical and Medical Affairs

Study Record Dates

First Submitted

November 18, 2022

First Posted

December 8, 2022

Study Start

February 7, 2023

Primary Completion

May 23, 2024

Study Completion

May 23, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations

US(1)