Smoking Cessation App for Mental Illness (Smart-T MH Trial)

Phase 2

Recruiting

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 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the feasibility of a smoking cessation app tailored for smokers with serious mental illness, who are otherwise underserved by current cessation programs.

Who is the study for?

This trial is for adults with serious mental illness who smoke at least 10 cigarettes a day, are willing to use nicotine replacement therapy (NRT), and can complete daily mobile surveys and carbon monoxide tests. They must be able to read English at a 6th-grade level or higher. Pregnant individuals or those with severe cognitive impairment cannot participate.

What is being tested?

The study compares three smoking cessation aids: QuitGuide app plus NRT, Smart-T Mental Health app plus NRT, and an enhanced version of the Smart-T app that also promotes adherence to NRT. Participants will use these aids over five weeks while attempting to quit smoking.

What are the potential side effects?

Potential side effects from using the apps may include frustration or stress if technical issues arise or if participants find it challenging to follow the program. Side effects from nicotine replacement therapy can include skin irritation from patches, sleep problems, nausea, heart palpitations, muscle pain and dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Biochemically-Verified Smoking Cessation

Secondary study objectives

Change in anxiety

Change in cessation motivation

Change in cigarette availability

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Smart-T Mental Health+ and NRTExperimental Treatment1 Intervention

Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. During the pre-quit and post-quit period, the app will also send messages that encourage the use of the nicotine patch and lozenges according to recommended practices. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive free NRT.

Group II: Smart-T Mental Health and NRTExperimental Treatment1 Intervention

Smart-T Mental Health provides smoking cessation and mental health content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. The Smart-T app contains multiple components including an EMA delivery and data transfer system, automated messages based upon EMA responses, and on-demand content. All participants will receive NRT.

Group III: NCI QuitGuide and NRTActive Control1 Intervention

The National Cancer Institute's QuitGuide app is a free smartphone app and is one of few apps that includes many of the recommendations detailed in the Clinical Practice Guideline. The QuitGuide app aims to help smokers understand their smoking patterns and develop the skills needed to quit smoking. QuitGuide provides content during the pre-quit and post-quit periods to prepare and support participants during their quit attempt. All participants will receive free NRT.

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