Pilot Study of a Smartphone-Based Vaping Cessation Program

Pivot Health Technologies

Status

Completed

Conditions

Vaping Cessation

Treatments

Behavioral: Pivot for Vape

Study type

Interventional

Funder types

Industry

Identifiers

NCT05642598

C-503

Details and patient eligibility

About

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

Full description

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.

Enrollment

73 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.)