What side effects are associated with this type of intervention?

Common treatments for tobacco use include behavioral therapies and pharmacotherapies such as nicotine replacement therapy (NRT), varenicline, and bupropion. NRT can cause side effects like skin irritation (patch), mouth soreness (gum), and throat irritation (lozenge). Varenicline may lead to nausea, insomnia, and in some cases, neuropsychiatric symptoms such as depression and agitation. Bupropion can cause insomnia, dry mouth, and an increased risk of seizures. Behavioral therapies, including those delivered via mobile apps, generally have minimal side effects but require consistent engagement and can be emotionally challenging.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of tobacco use, including varenicline (Chantix) and bupropion (Zyban), as well as various forms of nicotine replacement therapy (NRT) such as patches, gums, and lozenges. These treatments are often most effective when combined with behavioral support, which can include counseling and mobile app interventions. The CoQuit Mobile App, which uses a cognitive dissonance approach, aligns with this strategy by providing behavioral support to enhance the effectiveness of pharmacotherapies.

What other types of research exist?

Promising alternatives to the CoQuit Mobile App for tobacco use patients include: 1) iPath2Quit, a culturally specific mHealth intervention that has shown positive effects on nicotine replacement therapy (NRT) use and short-term abstinence. 2) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which has demonstrated improvements in sleep-related quality of life and insomnia symptoms, potentially aiding smoking cessation by addressing underlying sleep issues. 3) Combined pharmacotherapy and behavioral interventions, such as those integrating NRT or medications like varenicline with digital behavioral support, which have shown efficacy in smoking cessation.

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Behavioral Intervention

Mobile App for Smoking Cessation (CoQuit Trial)

N/A

Recruiting

Led By Dana Smith, PhD

Research Sponsored by Oregon Research Behavioral Intervention Strategies, Inc.

Eligibility Criteria Checklist

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

Must have

Age 18 or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-month, 3-month

Awards & highlights

Summary

This trial tests a mobile app called CoQuit, which helps people quit smoking by making them feel uncomfortable about their smoking habits. The study involves 500 adult smokers who want to quit. The app aims to increase quit attempts and smoke-free days by using a psychological technique.

Who is the study for?

This trial is for adult smokers over the age of 18 in the U.S. who smoke daily, speak English, have a valid mailing address, and want to quit smoking. They must also have access to a smartphone with video capability.

What is being tested?

The study is testing two mobile apps: one provides tips for quitting smoking (Tips App), while the other combines these tips with cognitive dissonance strategies to help quit smoking (CoQuit App).

What are the potential side effects?

Since this trial involves using mobile apps, there are no direct medical side effects. However, users may experience frustration or stress if they find it difficult to follow the app's guidance.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-month, 3-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month, 3-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month, 3-month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cognitive Dissonance Thermometer

Contemplation Ladder

Fagerstrom Tobacco Dependence Scale

+1 more

Secondary study objectives

Consumer Satisfaction and Program Evaluation

Program Engagement

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CoQuit App - Cognitive Dissonance Based Smoking CessationExperimental Treatment1 Intervention

This group will receive daily smoking cessation tips and will be asked to complete activities within the app that are designed to induce cognitive dissonance, create and share videos related to the activities with an online group, and provide support to other group members

Group II: Comparison App - Smoking Cessation Support without Cognitive Dissonance ActivitiesActive Control1 Intervention

This group will use an app that consists of tips for quitting cigarettes but does not include the cognitive dissonance component.

0 / 1Eligibility 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

Common treatments for tobacco use include cognitive dissonance-based interventions, behavioral support, and pharmacotherapy. Cognitive dissonance interventions, like the CoQuit Mobile App, create psychological conflict by highlighting the inconsistency between smoking and the desire to quit, motivating change. Behavioral support, such as counseling and mindfulness, helps develop coping strategies and manage cravings. Pharmacotherapy, including nicotine replacement therapy (NRT), varenicline, and bupropion, reduces withdrawal symptoms and cravings. Combining these methods is often more effective, addressing both psychological and physiological aspects of tobacco dependence.

A Qualitative Examination of Stay Quit Coach, A Mobile Application for Veteran Smokers With Posttraumatic Stress Disorder.Maintaining abstinence from smoking after a period of enforced abstinence - systematic review, meta-analysis and analysis of behaviour change techniques with a focus on mental health.Educational Needs of Oncology Practitioners in a Regional Cancer Center in the Middle East-Improving the Content of Smoking Cessation Training Programs.

Find a Location

Who is running the clinical trial?

Oregon Research Behavioral Intervention Strategies, Inc.Lead Sponsor

20 Previous Clinical Trials

8,238 Total Patients Enrolled

2 Trials studying Tobacco Use

5,346 Patients Enrolled for Tobacco Use

Dana Smith, PhDPrincipal InvestigatorOregon Research Behavioral Intervention Strategies, Inc.

2 Previous Clinical Trials

349 Total Patients Enrolled

~0 spots leftby Sep 2024

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