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Smoking Cessation App for Mental Health Disorders (MTQT Trial)

N/A
Recruiting
Led By Roger Vilardaga, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
Current DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month follow-up
Awards & highlights

MTQT Trial Summary

This trial will compare the effectiveness of a new app, Quit on the Go, to a standard of care smoking cessation intervention for people with serious mental illness.

Who is the study for?
This trial is for adults with serious mental illness (SMI) like schizophrenia or bipolar disorder who smoke at least 5 cigarettes daily, have functional impairment, and are currently in psychiatric treatment. They must want to quit smoking within the next six months and be able to use nicotine replacement therapy (NRT). Pregnant individuals, those in an acute psychotic episode, using e-cigarettes frequently, or receiving other cessation help can't join.Check my eligibility
What is being tested?
The study compares a new app called 'Quit on the Go', designed for people with SMI aiming to stop smoking, against standard care which includes brief advice and NRT such as patches, gum, or lozenges. Participants will be randomly assigned to one of these two approaches at Duke University and Univ. at Buffalo.See study design
What are the potential side effects?
Potential side effects from NRT may include skin irritation from patches; mouth soreness, hiccups or nausea from gum; throat irritation or coughing from lozenges. The app itself does not have physical side effects but could impact behavior related to quitting smoking.

MTQT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have difficulties with day-to-day activities due to my health condition.
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I have been diagnosed with a mental health condition like schizophrenia or bipolar disorder.
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I am 18 years old or older.
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I am willing and able to use nicotine replacement therapy.

MTQT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CO-verified 7-day point-prevalence abstinence at 6-month follow-up
Secondary outcome measures
30-day point prevalence abstinence rates
Average number of quit attempts per group
Biochemically confirmed 30-day point prevalence abstinence rates
+4 more
Other outcome measures
Average acceptance of physical smoking cravings
Average app usability scores
Average duration of app use
+5 more

MTQT Trial Design

2Treatment groups
Experimental Treatment
Group I: Brief Advice (Standard of Care)Experimental Treatment4 Interventions
Brief Advice and Combined Nicotine Replacement Therapy (patches and gum or lozenges) has been recommended by the US Clinical Practice Guidelines for patients with psychiatric illness. Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. The intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum).
Group II: "Quit on the Go" (formerly "Learn to Quit")Experimental Treatment5 Interventions
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief advice
2010
Completed Phase 4
~3480
Nicotine patch
2015
Completed Phase 4
~7330
Smartphone coaching
2021
N/A
~60
Nicotine gum
2015
Completed Phase 4
~2410
Nicotine Lozenges
2007
Completed Phase 3
~300

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,375 Previous Clinical Trials
3,426,473 Total Patients Enrolled
28 Trials studying Tobacco Use Disorder
4,758 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,714 Previous Clinical Trials
7,510,883 Total Patients Enrolled
45 Trials studying Tobacco Use Disorder
25,678 Patients Enrolled for Tobacco Use Disorder
University at BuffaloOTHER
132 Previous Clinical Trials
98,529 Total Patients Enrolled

Media Library

Quit on the Go App Clinical Trial Eligibility Overview. Trial Name: NCT05030272 — N/A
Tobacco Use Disorder Research Study Groups: "Quit on the Go" (formerly "Learn to Quit"), Brief Advice (Standard of Care)
Tobacco Use Disorder Clinical Trial 2023: Quit on the Go App Highlights & Side Effects. Trial Name: NCT05030272 — N/A
Quit on the Go App 2023 Treatment Timeline for Medical Study. Trial Name: NCT05030272 — N/A
Tobacco Use Disorder Patient Testimony for trial: Trial Name: NCT05030272 — N/A

Frequently Asked Questions

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

Are there any available spots for participants in this research experiment?

"This clinical trial is currently in search of participants, and its information on clinicialtrials.gov was initially posted on September 21st 2021 before being modified most recently on October 3rd 2022."

Answered by AI

Is there a predetermined limit to the number of participants accepted into this clinical investigation?

"Correct. Clinicaltrials.gov data reveals that this clinical trial, published on September 21st 2021, is actively searching for 450 participants from 1 site."

Answered by AI

Has the Learn to Quit App been used in any prior studies?

"Presently, 71 clinical trials are underway for the Learn to Quit App. Of those studies 5 have progressed to Phase 3 of research. Although Green Bay Wisconsin is where many of these experiments originate from, there exist 204 sites across America running tests on this treatment regimen."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
North Carolina
How old are they?
18 - 65
What site did they apply to?
Duke University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1

Why did patients apply to this trial?

I really want to quit smoking and need some help with it. I have tried taking Wellbutrin for smoking cessation, but had an adverse reaction. I would like to try another method.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do the visits take? How often are screening visits?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
2021. "Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05030272.
All > Mental Illness > Bipolar Disorder
~107 spots leftby Apr 2025
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