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Mobile App + NRT for Quitting Smoking

N/A

Recruiting

Research Sponsored by University of Houston

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Be older than 18 years old

Must not have

Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers (via self-report during the phone screen)

Younger than 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to end of study (phase ii end of study = week 6 follow up; phase iii end of study = 54 week follow up)

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to test a mobile app intervention targeting African American smokers' sensitivity to interoceptive stress.

Who is the study for?

This trial is for African American adults who smoke at least 5 cigarettes daily for over 2 years, have high anxiety sensitivity, and are motivated to quit. They must be fluent in English, willing to use nicotine replacement therapy (NRT), and able to complete surveys. Excluded are those under ongoing psychotherapy for anxiety or depression, using other smoking cessation aids, with recent heart attacks or uncontrolled high blood pressure.

What is being tested?

The study tests a mobile app called MASP designed to help African American smokers manage stress related to quitting by providing educational content on tobacco history within their community. It's compared with the QuitGuide app; both groups receive NRT. Participants will be randomly assigned to one of these interventions.

What are the potential side effects?

Potential side effects mainly relate to the nicotine replacement therapy (NRT) used alongside the apps and can include nausea, headaches, skin irritation from patches, difficulty sleeping, and dizziness.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using medication or therapy to quit smoking not given by this study's team.

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I am under 18 years old.

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I am not fluent in English.

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My high blood pressure is not controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to end of study (phase ii end of study = week 6 follow up; phase iii end of study = 54 week follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to end of study (phase ii end of study = week 6 follow up; phase iii end of study = 54 week follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to end of study (phase ii end of study = week 6 follow up; phase iii end of study = 54 week follow up) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

A qualitative interview will be used to evaluate the mobile app for style and presentation, perceived utility, ease of use, usefulness of features, and willingness to refer to a friend.

Change in Carbon Monoxide levels at Baseline as measured by the Carbon Monoxide Analysis (Phone Bedfont iCO Smokerlyzer) at follow up appointments.

Levels of satisfaction and perceived treatment quality regarding the intervention, as assessed by the Treatment Quality and Satisfaction Survey

Secondary study objectives

Change from Baseline in anxiety related impairment on the 5-item Overall Anxiety Severity and Impairment Scale at follow-up appointments.

Change from Baseline in depression related impairment on the 5-item Overall Depression Severity and Impairment Scale at subsequent follow-up appointments.

Change from Screener in levels of anxiety sensitivity on the 5-point Short Scale Anxiety Sensitivity Index at follow up appointments.

+8 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: QuitGuide app + NRTExperimental Treatment1 Intervention

The QuitGuide app is a standard of care app that allows users to track their nicotine cravings, and provides users with motivational messages.

Group II: MASP app + NRTExperimental Treatment1 Intervention

MASP is an intervention designed to assist African American smokers with anxiety sensitivity quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal.

0 / 5Eligibility criteria met