Nicotine AddictionPhase 1NCT03069482
Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
A Phase 1 study testing Learn to Quit App, Nicotine patch and Nicotine lozenge in people with Nicotine Addiction and Serious Mental Illness, run by Duke University at 1 site in United States.
Trial summary
Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Addiction, Serious Mental Illness
- What is being tested?
- Learn to Quit App, Nicotine patch and Nicotine lozenge
- 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
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 17 Jan 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or recurring depressive disorder
- Smoking ≥ 5 cigarettes per day over the past 30 days
- Desire to quit smoking in the next 30 days
- Willing and medically eligible to use Nicotine Replacement Therapy
- Fluent in spoken and written English
- Working email, mailing address, or alternative contact person
- Taking psychiatric medications as prescribed by their provider
- Stable housing
Who cannot join
- Problematic alcohol or illicit drug use in the last 30 days
- Acute psychotic episode, unsafe to participate in the study, or psychiatrically unstable
- Pregnant, breastfeeding, or having the intention to become pregnant in the next 4 months
- Hearing, comprehension, or visual limitations that preclude study participation
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
- Using non-cigarette forms of tobacco as the primary source of nicotine (e.g. e-cigarettes, chew)
Trial locations and contacts
1 site in 1 country.
About this study
Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures.
Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness.
Read more
However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population?
Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.
Read the detailed description
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion 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.
This feasibility trial will test whether a tailored smoking cessation app for people with serious mental illness, Learn to Quit, results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population, NCI QuitGuide. The trial will also demonstrate whether it is possible to (a) feasibly recruit and retain individuals with serious mental illness in an mHealth clinical trial, and (b) successfully gather smoking cessation outcomes. Ninety individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Learn to Quit app. In the comparator condition, participants will use the NCI QuitGuide app. Participants in both conditions will receive Nicotine Replacement Therapy (standard dosing of nicotine patch + 1-week course of 4mg nicotine lozenges) and technical coaching. Study duration will be 4 months, with four follow-up appointments at 1-month, 2-month, 3-month, and 4-months.
- Conditions
- Nicotine Addiction, Serious Mental Illness
- Being tested
- Learn to Quit App, Nicotine patch, Nicotine lozenge, Technical Coaching, NCI QuitGuide App
- Keywords
- Smoking, mHealth, Serious Mental Illness, Acceptance and Commitment Therapy, US DHHS Clinical Practice Guidelines
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learn to Quit AppDevice
A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods.
Nicotine patchDrug
Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
Nicotine lozengeDrug
Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
Technical CoachingBehavioural
Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance.
NCI QuitGuide AppDevice
A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Learn to Quit App; Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Technical Coaching |
| NCI QuitGuide | Active comparator | A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. Receives: Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Technical Coaching; Device: NCI QuitGuide App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of App Use
Frequency of app openings in each group
Measured: Daily throughout study duration, 4 months
Duration of App Use
Mean duration of app use in each group over the course of study participation (4 months)
Measured: Daily throughout study duration, 4 months
Feasibility as Measured by Study Accrual Relative to Recruitment Goal
Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.
Measured: Approximately 15 months
Feasibility as Measured by Study Attrition
Number and percentage of subjects who complete 4-month follow up assessment
Measured: 4-months
Recruitment Yield Effort
Percent of subjects responding to ads and clinician referrals
Measured: Approximately 15 months
Feasibility of Measurement Strategy
Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
Measured: Approximately 19 months
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Measured: 1-month follow-up
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Measured: 2-month follow-up
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Measured: 3-month follow-up
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Measured: 4-month follow-up
Secondary outcomes (45)
Biochemically Confirmed 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Measured: 1 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Measured: 2 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 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 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Measured: 4 month follow-up
Biochemically Confirmed Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. 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, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Measured: 1 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. 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, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Measured: 2 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. 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, AND by a result of ≤ 6 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 Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. 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, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Measured: 4 month follow up
30-day Point Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Measured: 1 month follow up
30-day Point Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Measured: 2 month follow up
30-day Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Measured: 3 month follow up
30-day Point Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Measured: 4 month follow up
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Measured: 1 month follow up
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Measured: 2 month follow up
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Measured: 3 month follow up
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Measured: 4 month follow up
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Measured: 1 month follow up
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Measured: 2 month follow up
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Measured: 3 month follow up
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Measured: 4 month follow up
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Measured: 1 month follow up
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Measured: 2 month follow up
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Measured: 3 month follow up
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Measured: 4 month follow up
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence
The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating "no dependence" and the highest score indicating "very dependent"
Measured: Baseline to 1, 2, 3 and 4 month follow up
Change in Average Number of Cigarettes Smoked Per Day
Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.
Measured: Baseline to 1, 2, 3 and 4 month follow up
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Measured: 1 month follow up
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Measured: 2 month follow up
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Measured: 3 month follow up
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Measured: 4 month follow up
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Measured: 1 month follow up
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Measured: 2 month follow up
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Measured: 3 month follow up
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Measured: 4 month follow up
Affect Ratings - Learn to Quit
Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.
Measured: Daily throughout study duration, 4 months
Affect Ratings - QuitGuide
Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day.
Measured: Daily throughout study, 4 months
Smoking Cravings
Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke.
Measured: Daily throughout study duration, 4 months
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Measured: 1 month follow up
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Measured: 2 month follow up
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Measured: 3 month follow up
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Measured: 4 month follow up
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Measured: 1 month follow up
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Measured: 2 month follow up
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Measured: 3 month follow up
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Measured: 4 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 posted3 Mar 2017
- Study start15 May 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be assigned to one of two smoking cessation apps for the duration of the study: Learn to Quit or NCI QuitGuide. One app was designed to address the needs of people with serious mental illness (Learn to Quit) and the other was designed for the general population (NCI QuitGuide).
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Roger Vilardaga, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069482
- Sponsor's protocol ID
- Pro00075165
- Other IDs
- 4R00DA037276-03
- Status last verified
- Oct 2020
- First submitted
- 22 Feb 2017
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Browne J, Halverson TF, Vilardaga R. Engagement with a digital therapeutic for smoking cessation designed for persons with psychiatric illness fully mediates smoking outcomes in a pilot randomized controlled trial. Transl Behav Med. 2021 Sep 15;11(9):1717-1725. doi: 10.1093/tbm/ibab100.
PubMed 34347865
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT03069482
- Acronym / sponsor ID
- Pro00075165
- Conditions
- Nicotine Addiction, Serious Mental Illness
- Keywords
- Smoking, mHealth, Serious Mental Illness, Acceptance and Commitment Therapy, US DHHS Clinical Practice Guidelines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures.
Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness.
However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population?
Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.
Detailed description
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion 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.
This feasibility trial will test whether a tailored smoking cessation app for people with serious mental illness, Learn to Quit, results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population, NCI QuitGuide. The trial will also demonstrate whether it is possible to (a) feasibly recruit and retain individuals with serious mental illness in an mHealth clinical trial, and (b) successfully gather smoking cessation outcomes. Ninety individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Learn to Quit app. In the comparator condition, participants will use the NCI QuitGuide app. Participants in both conditions will receive Nicotine Replacement Therapy (standard dosing of nicotine patch + 1-week course of 4mg nicotine lozenges) and technical coaching. Study duration will be 4 months, with four follow-up appointments at 1-month, 2-month, 3-month, and 4-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be assigned to one of two smoking cessation apps for the duration of the study: Learn to Quit or NCI QuitGuide. One app was designed to address the needs of people with serious mental illness (Learn to Quit) and the other was designed for the general population (NCI QuitGuide).
| Arm | Type | Receives |
|---|---|---|
| Learn to Quit | Experimental | Device: Learn to Quit App, Drug: Nicotine patch, Drug: Nicotine lozenge, Behavioral: Technical CoachingA 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. |
| NCI QuitGuide | Active comparator | Drug: Nicotine patch, Drug: Nicotine lozenge, Behavioral: Technical Coaching, Device: NCI QuitGuide AppA smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or recurring depressive disorder
- Smoking ≥ 5 cigarettes per day over the past 30 days
- Desire to quit smoking in the next 30 days
- Willing and medically eligible to use Nicotine Replacement Therapy
- Fluent in spoken and written English
Key exclusion criteria (6 listed)
- Problematic alcohol or illicit drug use in the last 30 days
- Acute psychotic episode, unsafe to participate in the study, or psychiatrically unstable
- Pregnant, breastfeeding, or having the intention to become pregnant in the next 4 months
- Hearing, comprehension, or visual limitations that preclude study participation
- Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation
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 |
|---|---|---|
| Learn to Quit AppA smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods. | Device | Learn to Quit |
| Nicotine patchParticipants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines. | Drug | Learn to Quit, NCI QuitGuide |
| Nicotine lozengeEach participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines. | Drug | Learn to Quit, NCI QuitGuide |
| Technical CoachingCoaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance. | Behavioural | Learn to Quit, NCI QuitGuide |
| NCI QuitGuide AppA smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies). | Device | NCI QuitGuide |
Primary outcome
Days of App Use
Time frame: Daily throughout study duration, 4 months
Frequency of app openings in each group
Duration of App Use
Time frame: Daily throughout study duration, 4 months
Mean duration of app use in each group over the course of study participation (4 months)
Feasibility as Measured by Study Accrual Relative to Recruitment Goal
Time frame: Approximately 15 months
Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.
Feasibility as Measured by Study Attrition
Time frame: 4-months
Number and percentage of subjects who complete 4-month follow up assessment
Recruitment Yield Effort
Time frame: Approximately 15 months
Percent of subjects responding to ads and clinician referrals
Feasibility of Measurement Strategy
Time frame: Approximately 19 months
Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
Usability of App Design as Measured by the System Usability Scale (SUS)
Time frame: 1-month follow-up
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Usability of App Design as Measured by the System Usability Scale (SUS)
Time frame: 2-month follow-up
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Usability of App Design as Measured by the System Usability Scale (SUS)
Time frame: 3-month follow-up
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Usability of App Design as Measured by the System Usability Scale (SUS)
Time frame: 4-month follow-up
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
45 secondary outcomes
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time frame: 1 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time frame: 2 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time frame: 3 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time frame: 4 month follow-up
Biochemically Confirmed Prolonged Abstinence Rates
Time frame: 1 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Time frame: 2 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Time frame: 3 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Time frame: 4 month follow up
30-day Point Prevalence Abstinence Rates
Time frame: 1 month follow up
30-day Point Prevalence Abstinence Rates
Time frame: 2 month follow up
30-day Prevalence Abstinence Rates
Time frame: 3 month follow up
30-day Point Prevalence Abstinence Rates
Time frame: 4 month follow up
7-day Point Prevalence Abstinence
Time frame: 1 month follow up
7-day Point Prevalence Abstinence
Time frame: 2 month follow up
7-day Point Prevalence Abstinence
Time frame: 3 month follow up
7-day Point Prevalence Abstinence
Time frame: 4 month follow up
24-hour Point Prevalence Abstinence
Time frame: 1 month follow up
24-hour Point Prevalence Abstinence
Time frame: 2 month follow up
24-hour Point Prevalence Abstinence
Time frame: 3 month follow up
24-hour Point Prevalence Abstinence
Time frame: 4 month follow up
Average Number of Quit Attempts Per Arm
Time frame: 1 month follow up
Average Number of Quit Attempts Per Arm
Time frame: 2 month follow up
Average Number of Quit Attempts Per Arm
Time frame: 3 month follow up
Average Number of Quit Attempts Per Arm
Time frame: 4 month follow up
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence
Time frame: Baseline to 1, 2, 3 and 4 month follow up
Change in Average Number of Cigarettes Smoked Per Day
Time frame: Baseline to 1, 2, 3 and 4 month follow up
Nicotine Replacement Patch Utilization
Time frame: 1 month follow up
Nicotine Replacement Patch Utilization
Time frame: 2 month follow up
Nicotine Replacement Patch Utilization
Time frame: 3 month follow up
Nicotine Replacement Patch Utilization
Time frame: 4 month follow up
Nicotine Replacement Lozenge Utilization
Time frame: 1 month follow up
Nicotine Replacement Lozenge Utilization
Time frame: 2 month follow up
Nicotine Replacement Lozenge Utilization
Time frame: 3 month follow up
Nicotine Replacement Lozenge Utilization
Time frame: 4 month follow up
Affect Ratings - Learn to Quit
Time frame: Daily throughout study duration, 4 months
Affect Ratings - QuitGuide
Time frame: Daily throughout study, 4 months
Smoking Cravings
Time frame: Daily throughout study duration, 4 months
Psychotic Symptoms
Time frame: 1 month follow up
Psychotic Symptoms
Time frame: 2 month follow up
Psychotic Symptoms
Time frame: 3 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34347865Browne J, Halverson TF, Vilardaga R. Engagement with a digital therapeutic for smoking cessation designed for persons with psychiatric illness fully mediates smoking outcomes in a pilot randomized controlled trial. Transl Behav Med. 2021 Sep 15;11(9):1717-1725. doi: 10.1093/tbm/ibab100.
- Individual participant dataSharing planned: Undecided
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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
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Learn to Quit App, Nicotine patch and Nicotine lozenge in people with Nicotine Addiction and Serious Mental Illness, run by Duke University at 1 site 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 8 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Days of App Use (time frame: Daily throughout study duration, 4 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069482, which also lists 1 linked publication.
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 10 Nov 2020.