NCT04955639

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Jennifer Marler, MD · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed 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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
OTHER	Control	Standard of Care - Control Smoking Cessation Program
OTHER	Pivot	Pivot Program Smoking Cessation Program

Timeline

• Start date: 2021-06-03
• Primary completion: 2022-04-27
• Completion: 2023-11-17
• First posted: 2021-07-09
• Last updated: 2024-07-01
• Results posted: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study