Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program

Jennifer Marler, MD

Status

Completed

Conditions

Smoking Cessation

Treatments

Other: Control

Other: Pivot

Study type

Interventional

Funder types

Industry

Identifiers

NCT04955639

C-650

Details and patient eligibility

About

Two-arm, parallel-group, non-crossover, single-center pilot randomized controlled trial, enrolling up to 180 participants to evaluate the effect of the Pivot smoking cessation program (intervention) compared to usual care (commercially available app smoking cessation program plus optional nicotine replacement therapy, control).

Full description

The present pilot randomized controlled trial compares user engagement and retention, change in attitudes towards quitting smoking, change in smoking behavior and participant feedback in adult smokers randomized either to the Pivot (intervention) or commercially available (control) smoking cessation programs.

We aim to assess participants' use of Pivot program and commercially available program. There will be a focus on assessing use and engagement, changes in attitudes towards quitting smoking and changes in smoking behavior over the course of the 2-year study, as well as participant feedback on the set-up, design, use experience, and impact of each program.

Enrollment

188 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

21+ years of age
Current daily cigarette smokers (at least 5 cigarettes per day) for the past 12 months
Plans to quit smoking in the next 30 days
Resident of the United States
Able to read and comprehend English
Owns and uses a smart phone 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 smart phone
Comfortable downloading and using smart phone apps
Willing to sign the Informed Consent Form

Exclusion criteria

Pregnancy (self-reported)
Health contraindications to nicotine replacement therapy (NRT) use (irregular heartbeat, high blood pressure not controlled with medication, heart attack or stroke in last 2 months, pregnant or breast feeding, skin allergies to adhesive tape or serious skin problems, stomach ulcers, history of seizures)
Using other smoking cessation support, including apps and/or actively taking medication to quit smoking
Daily marijuana use
Residence with another person who is a participant in this study
Immediate family member is a participant in this study
Failure to provide contact or collateral information, failure to verify email address, and/or failure to demonstrate videoconference capability
Participation in a previous study sponsored by Carrot Inc.