Tobacco Use DisorderMTQTNCT05030272
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
A study testing Quit on the Go App (formerly "Learn to Quit " App), Brief advice and Nicotine patch in people with Tobacco Use Disorder and Mental Illness, run by Wake Forest University Health Sciences at 3 sites in United States.
Trial summary
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder
- What is being tested?
- Quit on the Go App (formerly "Learn to Quit " App), Brief advice and Nicotine patch
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Sep 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
- Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
- Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
- Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
- Age 18 and older;
- Willing and medically eligible to use NRT;
- Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).
Who cannot join
- Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
- Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
- Being pregnant or the intention to become pregnant in the next 6 months;
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
- Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days.
- Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University at Buffalo
Buffalo, New York, 14260-1660
Duke University
Durham, North Carolina, 27705
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).
Read the detailed description
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to 317 billion dollar expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide-reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. However, our research has shown that apps developed for the general public have inadequate levels usability and engagement in people with serious mental illness.
In a previous pilot trial of a tailored smoking cessation app for people with serious mental illness, Learn to Quit (NCT03069482), we identified successful recruitment and retention methods for smokers with SMI, demonstrated a 4-fold increase in objectively measured interactions of the novel app, obtained promising cessation rates for the experimental app (12% for Quit on the Go formerly "Learn to Quit" versus 3% for NCI QuitGuide), and identified a reliable methodological approach to conduct a fully-powered randomized controlled trial.
Based on this pilot work, we plan to conduct a clinical trial to test this new model in a diverse and representative sample of the SMI population. Specifically, the proposed trial will test whether a tailored smoking cessation app for people with serious mental illness, Quit on the Go, results in higher levels of smoking abstinence compared to a standard of care intervention for this psychiatric population, Brief Advice. Both interventions will receive combined nicotine replacement therapy. The second aim of this trial is to test a mechanistic model of app efficacy by examining mediators of app engagement and treatment outcomes. Finally, the trial will evaluate the cost-effectiveness of these interventions to inform public health policy regard the use of mHealth in this population.
In a multi-site, two-arm randomized controlled trial, 450 individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Quit on the Go app. In the comparator condition, participants will receive Brief Advice for smoking cessation. Participants in both conditions will receive combined Nicotine Replacement Therapy (standard dosing of nicotine patch plus 5 week course of nicotine gums). Study duration will be 6 months, with 3 follow-up appointments at 1-month, 3-month, and 6-months. Our proposed methods are appropriate given our established procedures during our pilot trial regard to participant assignment, delivery of interventions, data collection and analysis (NCT03069482).
The proposed study meets NIDA's major programmatic priorities of using innovative technologies (e.g., smartphones) and integrating behavioral and pharmacological interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The proposal addresses a serious problem -- high smoking rates in people with SMI -- in a high priority, high cost population, by delivering a novel behavioral intervention for smoking cessation in "real-world" settings. If shown to be effective, the proposed intervention will provide a new model for delivering inexpensive, widely accessible smoking cessation interventions in adults with SMI.
- Conditions
- Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder
- Being tested
- Quit on the Go App (formerly "Learn to Quit " App), Brief advice, Nicotine patch, Smartphone coaching, Nicotine gum
- Medical subject headings
- Tobacco Use Disorder, Mental Disorders, Bipolar Disorder, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit on the Go App (formerly "Learn to Quit " App)Device
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.
Brief adviceBehavioural
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.
Nicotine patchDrug
Also called NRT
All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.
Smartphone coachingBehavioural
Participants randomized to the smartphone app intervention will receive 4 weeks of smartphone coaching given by research staff. The coaching is meant to be a time to address any issues that may rise with the participants' study smartphone or app.
Nicotine gumDrug
Also called NRT
Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Nicotine LozengesDrug
Also called NRT
In cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
| Study group | Role | What they receive |
|---|---|---|
| "Quit on the Go" (formerly "Learn to Quit") | Experimental | 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. Receives: Device: Quit on the Go App (formerly "Learn to Quit " App); Drug: Nicotine patch; Behavioral: Smartphone coaching; Drug: Nicotine gum; Drug: Nicotine Lozenges |
| Brief Advice (Standard of Care) | Other | 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). Receives: Behavioral: Brief advice; Drug: Nicotine patch; Drug: Nicotine gum; Drug: Nicotine Lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO-verified 7-day point-prevalence abstinence at 6-month follow-up
Abstinence is determined by a self-report of not smoking any tobacco product for greater than or equal to 7 days prior to Week 24 and biochemically verified by an expired carbon monoxide breath test reading of < 5 ppm at Week 24. If the participant does not meet both criteria, they are not considered abstinent.
As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 5 ppm.
Measured: At 24 weeks from Baseline
Secondary outcomes (17)
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Measured: 1 month follow-up
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Measured: 3 month follow-up
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Measured: 6 month follow-up
Average number of quit attempts per group
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Measured: 1 month follow-up
Average number of quit attempts per group
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Measured: 3 month follow-up
Average number of quit attempts per group
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Measured: 6 month follow-up
Time to 7-day relapse
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Measured: 1 month follow-up
Time to 7-day relapse
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Measured: 3 month follow-up
Time to 7-day relapse
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Measured: 6 month follow-up
30-day point prevalence abstinence rates
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the timepoint.
Measured: 1 month follow-up
Biochemically confirmed 30-day point prevalence abstinence rates
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Measured: 3 month follow-up
Biochemically confirmed 30-day point prevalence abstinence rates
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Measured: 6 month follow-up
Prolonged abstinence rates
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Measured: 3 month follow-up
Prolonged abstinence rates
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Measured: 6 month follow-up
Continuous abstinence rates
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point.
Measured: 1 month follow-up
Continuous abstinence rates
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm).
Measured: 3 month follow-up
Continuous abstinence rates
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm).
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start21 Sep 2021
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Roger Vilardaga, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030272
- Sponsor's protocol ID
- IRB00110770
- Other IDs
- R01DA047301
- Acronym
- MTQT
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
- ClinicalTrials.gov ID
- NCT05030272
- Acronym / sponsor ID
- MTQT / IRB00110770
- Conditions
- Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).
Detailed description
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to 317 billion dollar expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide-reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. However, our research has shown that apps developed for the general public have inadequate levels usability and engagement in people with serious mental illness.
In a previous pilot trial of a tailored smoking cessation app for people with serious mental illness, Learn to Quit (NCT03069482), we identified successful recruitment and retention methods for smokers with SMI, demonstrated a 4-fold increase in objectively measured interactions of the novel app, obtained promising cessation rates for the experimental app (12% for Quit on the Go formerly "Learn to Quit" versus 3% for NCI QuitGuide), and identified a reliable methodological approach to conduct a fully-powered randomized controlled trial.
Based on this pilot work, we plan to conduct a clinical trial to test this new model in a diverse and representative sample of the SMI population. Specifically, the proposed trial will test whether a tailored smoking cessation app for people with serious mental illness, Quit on the Go, results in higher levels of smoking abstinence compared to a standard of care intervention for this psychiatric population, Brief Advice. Both interventions will receive combined nicotine replacement therapy. The second aim of this trial is to test a mechanistic model of app efficacy by examining mediators of app engagement and treatment outcomes. Finally, the trial will evaluate the cost-effectiveness of these interventions to inform public health policy regard the use of mHealth in this population.
In a multi-site, two-arm randomized controlled trial, 450 individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Quit on the Go app. In the comparator condition, participants will receive Brief Advice for smoking cessation. Participants in both conditions will receive combined Nicotine Replacement Therapy (standard dosing of nicotine patch plus 5 week course of nicotine gums). Study duration will be 6 months, with 3 follow-up appointments at 1-month, 3-month, and 6-months. Our proposed methods are appropriate given our established procedures during our pilot trial regard to participant assignment, delivery of interventions, data collection and analysis (NCT03069482).
The proposed study meets NIDA's major programmatic priorities of using innovative technologies (e.g., smartphones) and integrating behavioral and pharmacological interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The proposal addresses a serious problem -- high smoking rates in people with SMI -- in a high priority, high cost population, by delivering a novel behavioral intervention for smoking cessation in "real-world" settings. If shown to be effective, the proposed intervention will provide a new model for delivering inexpensive, widely accessible smoking cessation interventions in adults with SMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Quit on the Go" (formerly "Learn to Quit") | Experimental | Device: Quit on the Go App (formerly "Learn to Quit " App), Drug: Nicotine patch, Behavioral: Smartphone coaching, Drug: Nicotine gum, Drug: Nicotine LozengesA 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. |
| Brief Advice (Standard of Care) | Other | Behavioral: Brief advice, Drug: Nicotine patch, Drug: Nicotine gum, Drug: Nicotine LozengesBrief 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
- Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
- Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
- Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
- Age 18 and older;
Key exclusion criteria (6 listed)
- Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
- Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
- Being pregnant or the intention to become pregnant in the next 6 months;
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
- Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quit on the Go App (formerly "Learn to Quit " App)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. | Device | "Quit on the Go" (formerly "Learn to Quit") |
| Brief adviceBrief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. | Behavioural | Brief Advice (Standard of Care) |
| Nicotine patchAlso: NRTAll participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches. | Drug | "Quit on the Go" (formerly "Learn to Quit"), Brief Advice (Standard of Care) |
| Smartphone coachingParticipants randomized to the smartphone app intervention will receive 4 weeks of smartphone coaching given by research staff. The coaching is meant to be a time to address any issues that may rise with the participants' study smartphone or app. | Behavioural | "Quit on the Go" (formerly "Learn to Quit") |
| Nicotine gumAlso: NRTEach participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours. | Drug | "Quit on the Go" (formerly "Learn to Quit"), Brief Advice (Standard of Care) |
| Nicotine LozengesAlso: NRTIn cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours. | Drug | "Quit on the Go" (formerly "Learn to Quit"), Brief Advice (Standard of Care) |
Primary outcome
CO-verified 7-day point-prevalence abstinence at 6-month follow-up
Time frame: At 24 weeks from Baseline
Abstinence is determined by a self-report of not smoking any tobacco product for greater than or equal to 7 days prior to Week 24 and biochemically verified by an expired carbon monoxide breath test reading of < 5 ppm at Week 24. If the participant does not meet both criteria, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 5 ppm.
17 secondary outcomes
Change in average number of cigarettes smoked per day
Time frame: 1 month follow-up
Change in average number of cigarettes smoked per day
Time frame: 3 month follow-up
Change in average number of cigarettes smoked per day
Time frame: 6 month follow-up
Average number of quit attempts per group
Time frame: 1 month follow-up
Average number of quit attempts per group
Time frame: 3 month follow-up
Average number of quit attempts per group
Time frame: 6 month follow-up
Time to 7-day relapse
Time frame: 1 month follow-up
Time to 7-day relapse
Time frame: 3 month follow-up
Time to 7-day relapse
Time frame: 6 month follow-up
30-day point prevalence abstinence rates
Time frame: 1 month follow-up
Biochemically confirmed 30-day point prevalence abstinence rates
Time frame: 3 month follow-up
Biochemically confirmed 30-day point prevalence abstinence rates
Time frame: 6 month follow-up
Prolonged abstinence rates
Time frame: 3 month follow-up
Prolonged abstinence rates
Time frame: 6 month follow-up
Continuous abstinence rates
Time frame: 1 month follow-up
Continuous abstinence rates
Time frame: 3 month follow-up
Continuous abstinence rates
Time frame: 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Vilardaga, PhD principal investigator
Wake Forest University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quit on the Go App (formerly "Learn to Quit " App), Brief advice and Nicotine patch in people with Tobacco Use Disorder and Mental Illness, run by Wake Forest University Health Sciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CO-verified 7-day point-prevalence abstinence at 6-month follow-up (time frame: At 24 weeks from Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.