What side effects are associated with this type of intervention?

The most common treatments for Tobacco Use Disorder include nicotine replacement therapy (NRT), varenicline, and bupropion. NRT can cause side effects such as nasal irritation, taste disturbances, and skin reactions. Varenicline may lead to nausea, insomnia, and in some cases, neuropsychiatric symptoms like depression and anxiety. Bupropion is associated with insomnia, dry mouth, and a risk of seizures. Behavioral support, including mobile health solutions like the QuitBuddy app, generally has fewer side effects but may require user engagement and adherence to be effective.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of Tobacco Use Disorder, including nicotine replacement therapy (NRT) products like nicotine patches, gums, and lozenges, as well as prescription medications such as bupropion and varenicline. Bupropion is a dopamine-reuptake inhibitor also used for depression, while varenicline works by targeting nicotine receptors in the brain to reduce cravings and withdrawal symptoms. These pharmacotherapies are often used in conjunction with behavioral support, which can include counseling and digital interventions like smartphone apps. The QuitBuddy trial, which uses a GPS-enabled smartphone app for behavioral support, aligns with the trend of integrating technology to enhance smoking cessation efforts.

What other types of research exist?

Promising alternatives to QuitBuddy for Tobacco Use Disorder patients include: 1) The PhoS app, which prompts users to engage in physical activities to manage smoking cravings, showing preliminary efficacy in a randomized controlled trial. 2) Pharmacotherapy options such as varenicline, bupropion, and nicotine replacement therapies, which have been proven effective in various clinical trials. 3) Combined behavioral and pharmacological interventions, which have shown higher success rates in smoking cessation. 4) Cytisine, a plant-based alkaloid, which has demonstrated efficacy in helping smokers quit in several studies.

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Quitbuddy App + Support for Smoking Cessation

N/A

Waitlist Available

Led By Bryan W Heckman, Ph.D.

Research Sponsored by Bryan W. Heckman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured one day after a participant's target quit-date.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a smartphone app called QuitBuddy to help people quit smoking. It targets current smokers, especially from underserved communities, by using GPS to provide timely support and nicotine lozenges. The goal is to see if QuitBuddy is more effective in helping people stay smoke-free.

Who is the study for?

This trial is for English/Spanish-speaking adults over 21 who smoke at least 10 cigarettes daily for the past year and are ready to quit within a week using nicotine replacement therapy. It's not for those pregnant, breastfeeding, with recent heart issues or strokes, or using other tobacco products or cessation meds.

What is being tested?

The study tests Quitbuddy, a GPS-enabled app designed to help smokers quit and prevent relapse. It will be compared with another app by the National Cancer Institute. Participants also receive social/financial support to see if it enhances Quitbuddy's effectiveness.

What are the potential side effects?

While this trial primarily involves digital apps which do not have direct side effects like medications might, participants may experience typical nicotine withdrawal symptoms due to quitting smoking such as irritability, cravings, or difficulty concentrating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured one day after a participant's target quit-date.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured one day after a participant's target quit-date.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured one day after a participant's target quit-date. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abstinence Rate

Cravings

NRT Compliance

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: QuitbuddyExperimental Treatment3 Interventions

Participants will be assigned to use a smartphone app (QuitBuddy) that will automatically guide NRT treatment delivery through the integration of ecological momentary assessments (EMA) and GPS into personalized relapse prevention algorithms.

Group II: ControlActive Control3 Interventions

Control is intended to approximate the real-world experience where Participants will use The National Cancer Institute's smartphone app (QuitGuide) and will self-manage NRT treatment delivery based on written instructions.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Tobacco Use Disorder include pharmacotherapy and behavioral support. Pharmacotherapy options like nicotine replacement therapy (NRT), bupropion, and varenicline work by reducing withdrawal symptoms and cravings, and blocking the pleasurable effects of nicotine. Behavioral support, such as that provided by the QuitBuddy app, uses motivational interviewing, coping strategies, and real-time support to help patients manage triggers and maintain abstinence. This combination is effective because it addresses both the physical and behavioral aspects of smoking, increasing the chances of successful cessation.

Mobile phone-based messaging for tobacco cessation in low and middle-income countries: A systematic review.Game On? Smoking Cessation Through the Gamification of mHealth: A Longitudinal Qualitative Study.Effectiveness of a web-based self-help smoking cessation intervention: protocol of a randomised controlled trial.