Pilot Study of a Smartphone-Based Vaping Cessation Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2024-05-23

Brief Summary

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

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Detailed Description

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This is a prospective, open label, single center clinical study conducted with IRB approval enrolling up to 100 adult participants who report daily vaping. The study will be performed remotely on an ambulatory basis.

Participants will be asked to set up and use the "Pivot for Vape" program. The program includes an app, moderated online community, and SMS-based coaching with a tobacco treatment specialist. The study duration is 52 weeks, with the estimated active time using the program of up to 6 months and the time thereafter as follow-up. Participants will receive online questionnaires at intervals throughout the study.

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 for Vape" program, with a focus on assessing use and engagement, changes in attitudes towards quitting vaping and changes in vaping behavior over the course of the 1-year study, as well as participant feedback on the set-up, design, use experience, and impact of the program.

Conditions

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Vaping Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pivot for Vape

A commercially available mobile phone app and program for vaping cessation

Group Type EXPERIMENTAL

Pivot for Vape

Intervention Type BEHAVIORAL

"Pivot for Vape" vaping cessation smartphone app and program

Interventions

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Pivot for Vape

"Pivot for Vape" vaping cessation smartphone app and program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes