What side effects are associated with this type of intervention?

Behavioral support and cognitive-behavioral therapy (CBT) for Tobacco Use Disorder typically have minimal side effects, mainly involving emotional responses such as increased stress or anxiety. Nicotine replacement therapy (NRT) can cause skin irritation, nasal irritation, and gastrointestinal issues. Varenicline may lead to nausea, insomnia, and mood changes, while bupropion can cause insomnia, dry mouth, and rarely, seizures.

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 patches, gums, and lozenges, as well as prescription medications such as varenicline (Chantix) and bupropion (Zyban). These treatments are often used in conjunction with behavioral support and cognitive-behavioral therapy (CBT), which can be delivered through various methods, including smartphone mobile applications. These apps provide tools for stress reduction, coping strategies, and motivational support, enhancing the effectiveness of pharmacotherapies in helping individuals quit smoking.

What other types of research exist?

Promising, novel alternatives to smartphone mobile applications for treating Tobacco Use Disorder include: 1) Virtual Reality (VR) therapy, which immerses patients in controlled environments to practice coping strategies and reduce cravings. 2) Telehealth services, offering remote counseling and support through video calls, which can provide personalized care similar to in-person therapy. 3) Wearable devices that monitor physiological signals and deliver real-time interventions or feedback to manage cravings and stress. 4) Digital platforms that integrate AI-driven personalized coaching and support, offering tailored interventions based on user data and behavior patterns.

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Smartphone App for Smoking Cessation

N/A

Waitlist Available

Led By Jennifer A Minnix

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

MD Anderson patient between the ages of 18 to 65

Willing to set a quit date in the next 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks from start of study

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well two smartphone apps, KickAsh and Breathe2Relax, help smokers with depressive symptoms quit smoking. KickAsh teaches relaxation skills, and Breathe2Relax improves mood and encourages fun activities. KickAsh combines methods from various approaches to help smokers quit.

Who is the study for?

This trial is for English-speaking MD Anderson patients aged 18-65 who smoke daily, own an iOS device with regular app usage, and are willing to set a quit date within 30 days. They must have smoked for at least a year and either currently have or previously had depressive symptoms. People can't join if they're in another smoking cessation program or have health issues that make the study unsafe for them.

What is being tested?

The study is testing how effective smartphone apps are in helping smokers quit. Participants will use these apps as part of their smoking cessation treatment to see if it enhances their ability to stop smoking.

What are the potential side effects?

Since this trial involves using a mobile application and answering questionnaires, there aren't typical medical side effects. However, participants may experience stress or frustration related to quitting smoking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a patient at MD Anderson, aged between 18 and 65.

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I am willing to commit to quitting smoking within the next 30 days.

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I have or had depression symptoms.

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I can speak and understand English well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks from start of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks from start of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks from start of study for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Smoke

Evidence of improved mood in KickAsh and Breathe2Relax groups

Evidence of increased activity level in KickAsh and Breathe2Relax groups

+3 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

Group I: Group II (Breathe2Relax smartphone mobile application)Experimental Treatment2 Interventions

Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Group II: Group I (KickAsh smartphone mobile application)Experimental Treatment2 Interventions

Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

0 / 4Eligibility criteria met

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

The most common treatments for Tobacco Use Disorder include pharmacotherapy (e.g., nicotine replacement therapy, varenicline, bupropion) and behavioral interventions (e.g., cognitive-behavioral therapy, mindfulness, motivational interviewing). Pharmacotherapy works by reducing withdrawal symptoms and cravings, making it easier for patients to quit smoking. Behavioral interventions, such as cognitive-behavioral therapy (CBT), help patients identify and change smoking-related thoughts and behaviors, while mindfulness and motivational interviewing enhance self-awareness and motivation to quit. Smartphone mobile applications can augment these behavioral interventions by providing real-time support, tracking progress, and delivering personalized coping strategies. This matters for patients as it increases accessibility to continuous support, potentially improving quit rates and long-term abstinence.

A pilot randomized controlled trial of smartphone-assisted mindfulness-based intervention with contingency management for smokers with mood disorders.Mobile phone-based messaging for tobacco cessation in low and middle-income countries: A systematic review.A Qualitative Examination of Stay Quit Coach, A Mobile Application for Veteran Smokers With Posttraumatic Stress Disorder.