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Smoking Cessation App for Mental Health Disorders (MTQT Trial)

N/A
Recruiting
Led By Roger Vilardaga, PhD
Research Sponsored by Wake Forest University Health Sciences
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
Must not have
Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month follow-up
Awards & highlights

Summary

This trial will test a new smartphone app called Quit on the Go, designed to help people with serious mental illness quit smoking. The study will compare this app to traditional methods, with both groups also using nicotine patches and gum. The goal is to see if the app helps more people quit smoking and if it is cost-effective.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently getting help to quit smoking.

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

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

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
~6130
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?

Wake Forest University Health SciencesLead Sponsor
1,348 Previous Clinical Trials
1,030,565 Total Patients Enrolled
13 Trials studying Tobacco Use Disorder
4,284 Patients Enrolled for Tobacco Use Disorder
Duke UniversityLead Sponsor
2,441 Previous Clinical Trials
3,065,946 Total Patients Enrolled
28 Trials studying Tobacco Use Disorder
4,757 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,789 Previous Clinical Trials
8,137,694 Total Patients Enrolled
46 Trials studying Tobacco Use Disorder
25,801 Patients Enrolled for Tobacco Use Disorder

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
~54 spots leftby Apr 2025
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