Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

October 21, 2020 updated by: Duke University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Learn to Quit
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: Learn to Quit App
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.
Drug: Nicotine patch
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.
Drug: Nicotine lozenge
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.
Behavioral: Technical Coaching
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.
Active Comparator: NCI QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Drug: Nicotine patch
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.
Drug: Nicotine lozenge
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.
Behavioral: Technical Coaching
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.
Device: NCI QuitGuide App
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days of App Use
Time Frame: Daily throughout study duration, 4 months
Frequency of app openings in each group
Daily throughout study duration, 4 months
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)
Daily throughout study duration, 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.
Approximately 15 months
Feasibility as Measured by Study Attrition
Time Frame: 4-months
Number and percentage of subjects who complete 4-month follow up assessment
4-months
Recruitment Yield Effort
Time Frame: Approximately 15 months
Percent of subjects responding to ads and clinician referrals
Approximately 15 months
Feasibility of Measurement Strategy
Time Frame: Approximately 19 months
Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
Approximately 19 months
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.
1-month follow-up
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.
2-month follow-up
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.
3-month follow-up
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.
4-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time Frame: 1 month follow-up
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.
1 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time Frame: 2 month follow-up
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.
2 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time Frame: 3 month follow-up
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.
3 month follow-up
Biochemically Confirmed 7-day Point Prevalence Abstinence
Time Frame: 4 month follow-up
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.
4 month follow-up
Biochemically Confirmed Prolonged Abstinence Rates
Time Frame: 1 month follow up
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
1 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Time Frame: 2 month follow up
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
2 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Time Frame: 3 month follow up
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.
3 month follow up
Biochemically Confirmed Prolonged Abstinence Rates
Time Frame: 4 month follow up
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.
4 month follow up
30-day Point Prevalence Abstinence Rates
Time Frame: 1 month follow up
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
1 month follow up
30-day Point Prevalence Abstinence Rates
Time Frame: 2 month follow up
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
2 month follow up
30-day Prevalence Abstinence Rates
Time Frame: 3 month follow up
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
3 month follow up
30-day Point Prevalence Abstinence Rates
Time Frame: 4 month follow up
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
4 month follow up
7-day Point Prevalence Abstinence
Time Frame: 1 month follow up
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
1 month follow up
7-day Point Prevalence Abstinence
Time Frame: 2 month follow up
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
2 month follow up
7-day Point Prevalence Abstinence
Time Frame: 3 month follow up
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
3 month follow up
7-day Point Prevalence Abstinence
Time Frame: 4 month follow up
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
4 month follow up
24-hour Point Prevalence Abstinence
Time Frame: 1 month follow up
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
1 month follow up
24-hour Point Prevalence Abstinence
Time Frame: 2 month follow up
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
2 month follow up
24-hour Point Prevalence Abstinence
Time Frame: 3 month follow up
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
3 month follow up
24-hour Point Prevalence Abstinence
Time Frame: 4 month follow up
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
4 month follow up
Average Number of Quit Attempts Per Arm
Time Frame: 1 month follow up
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
1 month follow up
Average Number of Quit Attempts Per Arm
Time Frame: 2 month follow up
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
2 month follow up
Average Number of Quit Attempts Per Arm
Time Frame: 3 month follow up
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
3 month follow up
Average Number of Quit Attempts Per Arm
Time Frame: 4 month follow up
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
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
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"
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
Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.
Baseline to 1, 2, 3 and 4 month follow up
Nicotine Replacement Patch Utilization
Time Frame: 1 month follow up
Days of patch use over the last 30 days.
1 month follow up
Nicotine Replacement Patch Utilization
Time Frame: 2 month follow up
Days of patch use over the last 30 days.
2 month follow up
Nicotine Replacement Patch Utilization
Time Frame: 3 month follow up
Days of patch use over the last 30 days.
3 month follow up
Nicotine Replacement Patch Utilization
Time Frame: 4 month follow up
Days of patch use over the last 30 days.
4 month follow up
Nicotine Replacement Lozenge Utilization
Time Frame: 1 month follow up
Days of lozenge use over the last 30 days.
1 month follow up
Nicotine Replacement Lozenge Utilization
Time Frame: 2 month follow up
Days of lozenge use over the last 30 days.
2 month follow up
Nicotine Replacement Lozenge Utilization
Time Frame: 3 month follow up
Days of lozenge use over the last 30 days.
3 month follow up
Nicotine Replacement Lozenge Utilization
Time Frame: 4 month follow up
Days of lozenge use over the last 30 days.
4 month follow up
Affect Ratings - Learn to Quit
Time Frame: Daily throughout study duration, 4 months
Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.
Daily throughout study duration, 4 months
Affect Ratings - QuitGuide
Time Frame: Daily throughout study, 4 months
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.
Daily throughout study, 4 months
Smoking Cravings
Time Frame: Daily throughout study duration, 4 months
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.
Daily throughout study duration, 4 months
Psychotic Symptoms
Time Frame: 1 month follow up
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.
1 month follow up
Psychotic Symptoms
Time Frame: 2 month follow up
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.
2 month follow up
Psychotic Symptoms
Time Frame: 3 month follow up
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.
3 month follow up
Psychotic Symptoms
Time Frame: 4 month follow up
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.
4 month follow up
General Psychiatric Symptoms
Time Frame: 1 month follow up
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.
1 month follow up
General Psychiatric Symptoms
Time Frame: 2 month follow up
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.
2 month follow up
General Psychiatric Symptoms
Time Frame: 3 month follow up
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.
3 month follow up
General Psychiatric Symptoms
Time Frame: 4 month follow up
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.
4 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00075165
  • 4R00DA037276-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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