Equitable Smoking Relapse Prevention

Summary

The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are:

* Is Quitbuddy a good treatment for quitting smoking and "staying quit"?
* Will a second treatment that connects people to help for their social and financial needs improve Quitbuddy?

Participants will:

* get nicotine lozenges in the mail
* check in with the study team to report on their quitting progress after 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months

Researchers will compare Quitbuddy to an app made by the National Cancer Institute to see if Quitbuddy is better for helping people stay quit.

Conditions

• Tobacco Use Disorder
• Tobacco Dependence

Interventions

OTHER

Quitbuddy

Participants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed. Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD EMA/GPS smoking data collection. GPS guided NRT usage prompts, via hotspot algorithms, will be provided to participants in the Quitbuddy Arm. Participants will contribute four weeks of post-TQD EMA/GPS data to capture lapses and NRT use in real-time. Carbon Monoxide (CO) levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates). Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance.

OTHER

Control

Participants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed. Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD smoking data collection. Participants will contribute four weeks of post-TQD data to capture lapses and NRT use. CO levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates). Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance.

OTHER

SDoH Augmentation

The SDoH intervention is based on the findhelp.org online platform, with customization to meet the specific needs of the study and communities being served: includes validated SDoH assessments, personalized social needs searching based on priorities, access to the most comprehensive social service database, and a streamlined closed loop referral system that integrates with workflows.

OTHER

SDoH Control

No SDoH intervention

Sponsors & Collaborators

• City of Hope Medical Center

  collaborator OTHER

• Virginia Tech Carilion School of Medicine and Research Institute

  collaborator OTHER

• Bryan W. Heckman

  lead OTHER

Principal Investigators

• Bryan W Heckman, Ph.D. · Meharry Medical College

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-02

Primary Completion

2023-11-30

Completion

2023-11-30

Countries

• United States

Study Locations