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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-03

Study Completion Date

2023-11-17

Brief Summary

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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).

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Detailed Description

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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

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participant blinded to arm assignment but not to the smoking cessation program he/she is using.

Study Groups

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Control

A commercially available mobile phone app and program

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Standard of Care - Control Smoking Cessation Program

Pivot

Pivot mobile phone app and program

Group Type ACTIVE_COMPARATOR

Pivot

Intervention Type OTHER

Pivot Program Smoking Cessation Program

Interventions

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Control

Standard of Care - Control Smoking Cessation Program

Intervention Type OTHER

Pivot

Pivot Program Smoking Cessation Program

Intervention Type OTHER

Other Intervention Names

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Standard of Care Pivot Program

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes