"Quit on the Go" (formerly "Learn to Quit") for Tobacco Use Disorder
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
Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up6 month follow-up
Awards & highlights
No Placebo-Only Group
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Study 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.
Eligible Conditions
- Tobacco Use Disorder
- Bipolar Disorder
- Mental Health Disorders
- Schizoaffective Disorder
- Major Depressive Disorder
- Persistent Depressive Disorder
- Schizophrenia
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You smoke at least 5 cigarettes per day for the past 6 months.
Select...
You have been smoking at least 5 cigarettes every day for the past 6 months.
Select...
You are willing and able to use nicotine replacement therapy (NRT) if needed.
Select...
You really want to stop smoking and have made a serious commitment to quit within the next 6 months.
Select...
You must have a strong intention to quit smoking within the next six months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month follow-up
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 moreOther outcome measures
Average acceptance of physical smoking cravings
Average app usability scores
Average duration of app use
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
FDA approved
Smartphone coaching
2021
N/A
~60
Nicotine
FDA approved
Nicotine Lozenges
2007
Completed Phase 3
~300
Find a site
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,288 Previous Clinical Trials
3,100,177 Total Patients Enrolled
28 Trials studying Tobacco Use Disorder
4,758 Patients Enrolled for Tobacco Use Disorder
National Institutes of Health (NIH)NIH
2,611 Previous Clinical Trials
6,804,440 Total Patients Enrolled
44 Trials studying Tobacco Use Disorder
25,742 Patients Enrolled for Tobacco Use Disorder
University at BuffaloOTHER
127 Previous Clinical Trials
93,324 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,368 Previous Clinical Trials
2,048,666 Total Patients Enrolled
267 Trials studying Tobacco Use Disorder
48,350 Patients Enrolled for Tobacco Use Disorder
Roger Vilardaga, PhDPrincipal Investigator
Duke University1 Previous Clinical Trials
63 Total Patients Enrolled
1 Trials studying Tobacco Use Disorder
63 Patients Enrolled for Tobacco Use Disorder
Media Library
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
What questions have other patients asked about this trial?
How long do the visits take? How often are screening visits?
Patient
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.
Patient
How responsive is this trial?
Typically responds via
Email