What is the mechanism of action of this treatment?

The most common treatments for smoking cessation include pharmacologic methods, such as nicotine replacement therapy (NRT) and medications like varenicline and bupropion, which work by reducing withdrawal symptoms and cravings. Behavioral strategies, such as individual counseling, group therapy, and digital interventions like smartphone apps, provide psychological support and coping mechanisms. The OKquit smoking cessation app exemplifies a modern approach by offering tailored messages and on-demand content, which can enhance motivation and provide immediate support during critical moments. These mechanisms are crucial for smoking cessation patients as they address both the physical dependence on nicotine and the behavioral aspects of smoking, increasing the likelihood of successful quitting.

What side effects are associated with this type of intervention?

Common treatments for smoking cessation that involve tailored messages and on-demand content, such as mobile apps and digital health interventions, generally have minimal physical side effects. However, users may experience psychological effects such as increased anxiety, irritability, and mood swings, especially during the initial phase of quitting smoking. These interventions are designed to provide behavioral support and motivation, which can sometimes lead to frustration if progress is slower than expected. Overall, these digital interventions are considered safe and are primarily focused on supporting the user's mental and emotional journey to quit smoking.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for smoking cessation, including nicotine replacement therapy (NRT) products like patches, gums, and lozenges, as well as prescription medications such as bupropion (Zyban) and varenicline (Chantix). These treatments are often used in combination with behavioral support strategies, such as counseling and digital interventions. The OKquit smoking cessation app, which provides tailored messages and on-demand content, complements these pharmacotherapies by offering personalized behavioral support to enhance quit rates.

What other types of research exist?

Promising alternatives to the OKquit smoking cessation app for 2024 include: 1) Quit4baby, an interactive and intensive text messaging program for pregnant women. 2) SmokefreeMOM, an automated text-messaging program for pregnant smokers. 3) Smoke Free app with a supportive chatbot, which has shown increased engagement and short-term quit success. 4) Insight app, which provides daily check-ins and weekly surveys. These alternatives offer tailored messages, interactive support, and have demonstrated effectiveness in recent studies.

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Smartphone App for Smoking Cessation (OKquit Trial)

N/A

Recruiting

Led By Michael S Businelle, PhD

Research Sponsored by University of Oklahoma

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 27 weeks

Awards & highlights

OKquit Trial Summary

This trial will test the feasibility and initial efficacy of an app-based smoking cessation intervention for smokers who contact the Oklahoma Tobacco Helpline for services.

Who is the study for?

This trial is for adults in Oklahoma who smoke at least 5 cigarettes a day, are willing to quit within 21 days after starting the study, and can use a smartphone compatible with the Insight mHealth Platform. They must be able to complete daily and weekly surveys for 27 weeks. People with low health literacy (as measured by REALM-SF) or without an Oklahoma address are excluded.Check my eligibility

What is being tested?

The study tests a new smoking cessation app called OKquit against Standard Helpline Care provided by the Oklahoma Tobacco Helpline. Participants will either get standard care plus daily check-ins and weekly surveys through an app or this standard care along with additional features from the OKquit app.See study design

What are the potential side effects?

Since this trial involves using smartphone applications for smoking cessation, there aren't typical medical side effects; however, participants may experience stress or frustration if they find it difficult to quit smoking or use the technology.

OKquit Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~27 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Smoke

Secondary outcome measures

Cessation motivation

Treatment engagement

OKquit Trial Design

2Treatment groups

Active Control

Group I: The Standard Helpline Care (SC) groupActive Control1 Intervention

The SC group will receive standard Oklahoma Smoking Cessation Helpline care AND complete daily check-ins and weekly surveys for 27 weeks.

Group II: OKquit groupActive Control1 Intervention

The OKquit group will receive SC plus daily check-ins and weekly surveys for 27 weeks. In addition, the OKquit group will receive tailored smoking cessation messages in the smartphone application following completion of each survey. Further, the OKquit group will have access to on-demand smoking cessation content through the app.

Do I qualify?Apply below to find out

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 smoking cessation include pharmacologic methods, such as nicotine replacement therapy (NRT) and medications like varenicline and bupropion, which work by reducing withdrawal symptoms and cravings. Behavioral strategies, such as individual counseling, group therapy, and digital interventions like smartphone apps, provide psychological support and coping mechanisms. The OKquit smoking cessation app exemplifies a modern approach by offering tailored messages and on-demand content, which can enhance motivation and provide immediate support during critical moments. These mechanisms are crucial for smoking cessation patients as they address both the physical dependence on nicotine and the behavioral aspects of smoking, increasing the likelihood of successful quitting.

An international survey: Tobacco smoking cessation strategies within left ventricular assist device centers.Mobile phone-based messaging for tobacco cessation in low and middle-income countries: A systematic review.The natural history of efforts to stop smoking: a prospective cohort study.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,156 Total Patients Enrolled

Michael S Businelle, PhDPrincipal InvestigatorUniversity of Oklahoma

1 Previous Clinical Trials

453 Total Patients Enrolled

Media Library

OKquit Clinical Trial Eligibility Overview. Trial Name: NCT05539209 — N/A

Smoking Cessation Research Study Groups: The Standard Helpline Care (SC) group, OKquit group

Smoking Cessation Clinical Trial 2023: OKquit Highlights & Side Effects. Trial Name: NCT05539209 — N/A

OKquit 2023 Treatment Timeline for Medical Study. Trial Name: NCT05539209 — N/A

~172 spots leftby Jun 2025

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