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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
18 years of age or older, self-identify as African American, high Anxiety sensitivity defined as a SSASI score of ≥ 5 assessed during phone intake via the SSASI measure (cut-off score to identify high AS individuals), daily smoking (minimum of 10 cigarettes per day) for > 2 years (assessed at screening level by providing a picture of their pack of cigarettes in real-time to screen out non-smokers), motivated to quit smoking (> 5 on a 10-point scale), willing and able to complete all study surveys/assessments, willing to use NRT, and willing to quit smoking 2 weeks after completion of the baseline survey and receipt of study materials (e.g., iCO, nicotine replacement medications).
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

Study 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.Check my eligibility
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.See study design
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.
Select...
You are 18 years or older, African American, and smoke at least 10 cigarettes per day for more than 2 years. You also have high anxiety sensitivity, which will be measured during a phone interview. You must be willing to quit smoking, use nicotine replacement therapy, and complete all study surveys and assessments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

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

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.

Find a Location

Who is running the clinical trial?

University of HoustonLead Sponsor
146 Previous Clinical Trials
47,292 Total Patients Enrolled
University of OklahomaOTHER
455 Previous Clinical Trials
97,937 Total Patients Enrolled

Media Library

MASP app Clinical Trial Eligibility Overview. Trial Name: NCT04838236 — N/A
MASP app 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838236 — N/A
Tobacco Smoking Research Study Groups: MASP app + NRT, QuitGuide app + NRT
Tobacco Smoking Clinical Trial 2023: MASP app Highlights & Side Effects. Trial Name: NCT04838236 — N/A
Tobacco Smoking Patient Testimony for trial: Trial Name: NCT04838236 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate enrollment rate of participants for this research?

"Affirmative. The clinical trial's details hosted on the website clinicaltrials.gov reveals that recruitment is still ongoing for this study, which was initially posted in December 2021 and recently updated in March 2022. A total of 225 patients are needed to be recruited from 3 different medical institutions."

Answered by AI

Are enrollments for this trial currently being accepted?

"Affirmative. Clinicaltrials.gov displays that the study, initially posted on December 20th 2021, is currently recruiting individuals for enrollment - 225 people from 3 different locations in total."

Answered by AI

Is there a way to become involved in this medical research endeavor?

"This investigation is in search of 225 individuals who smoke tobacco and are between 18 and 64 years old. Furthermore, they must be African American, have a high Anxiety sensitivity (SSASI score ≥ 5), consume a minimum of 10 cigarettes daily for the past two years or more, possess motivation to quit smoking (score >5 on a 10-point scale), agree to complete all pertinent surveys/assessments, accept use NRT products if necessary, and plan to abstain from smoking 2 weeks after baseline survey completion with accession of study materials such as iCOs an nicotine replacements medications."

Answered by AI

Is the research study welcoming participants of advanced age?

"This research project requires participants to be between 18-64 years old. For those below this age, there are 4 separate trials available, and for those above it, 31 clinical studies can provide assistance."

Answered by AI

What is the ultimate goal of this research project?

"The primary goal of this trial, which will be evaluated over a 6 week period (in phases 2 and 3), is to monitor the change in carbon monoxide levels at baseline using Carbon Monoxide Analysis. Secondary objectives include analyzing how stress related to COVID-19 can influence smoking outcomes; evaluating changes in anxiety sensitivity with a 5-point Short Scale Anxiety Sensitivity Index; and exploring if there are any underlying effects on stress caused by racial/ethnic discrimination through utilizing the Jackson Heart Study Discrimination Instrument."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Anxiety and Health Research Lab / Substance Use Treatment Clinic

Why did patients apply to this trial?

This will be helping me out. Here to help others possibly.
PatientReceived 2+ prior treatments
~75 spots leftby Mar 2025