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

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

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).

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.

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.