Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings (MTQT)

November 4, 2026 updated by: Wake Forest University Health Sciences

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).

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 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 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.
343

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.
  • Not Applicable

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
    • New York
      • Buffalo, New York, United States, 14260-1660
        • University at Buffalo
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

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:

  1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
  2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
  3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
  4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
  5. Age 18 and older;
  6. Willing and medically eligible to use NRT;
  7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).

Exclusion Criteria

  1. 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.
  2. 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);
  3. Being pregnant or the intention to become pregnant in the next 6 months;
  4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
  5. Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days.
  6. 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).

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: "Quit on the Go" (formerly "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. 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.
Device: 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.

Drug: Nicotine patch

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.

Other Names:
  • NRT
Behavioral: Smartphone coaching

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.

Drug: Nicotine gum

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.

Other Names:
  • NRT
Drug: Nicotine Lozenges

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.

Other Names:
  • NRT
Other: Brief Advice (Standard of Care)

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).
Drug: Nicotine patch

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.

Other Names:
  • NRT
Drug: Nicotine gum

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.

Other Names:
  • NRT
Drug: Nicotine Lozenges

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.

Other Names:
  • NRT
Behavioral: Brief advice

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.

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
Bio-verified 7-day point-prevalence abstinence at 24 weeks
Time Frame: At 24 weeks from Baseline

Abstinence is binary, and requires both (a) self-report of no smoking at all for at least 7 days prior to week 24; and (b) biochemical verification [either expired CO breath test reading of < 5 ppm using the Belfont Micro+® Smokerlyzer test, or of < 6 ppm if using the iCOquit® Smokerlyzer test, or a cotinine level of less than or equal to 30 ng/ml if using an Alere iScreen saliva test]. 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, or fail to provide a breath and saliva sample at the time-point.
At 24 weeks from Baseline

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
Change in average number of cigarettes smoked per day
Time Frame: At 24 weeks from Baseline

Change in self-reported number of cigarettes smoked per day, averaged within groups.
At 24 weeks from Baseline
Average number of 24-hr quit attempts per group
Time Frame: At 24 weeks from Baseline

Average number of quit attempts self-reported per group between baseline and week 24. Quit attempts are defined by no smoking at all for 24 hours or more.
At 24 weeks from Baseline
7-day point prevalence abstinence rates
Time Frame: At 12 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
At 12 weeks from Baseline
7-day point prevalence abstinence rates
Time Frame: At 24 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the timepoint.
At 24 weeks from Baseline
30-day point prevalence abstinence rates
Time Frame: At 12 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
At 12 weeks from Baseline
30-day point prevalence abstinence rates
Time Frame: At 24 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days prior to the timepoint.
At 24 weeks from Baseline
Biochemically confirmed 7-day point prevalence abstinence rates
Time Frame: At 12 weeks from Baseline

Percent of subjects in each group self-reporting no smoking at all for greater or equal to 7 days prior to the time point. Abstinence requires both (a) self-report of no smoking at all for at least 7 days prior to week 24; and (b) biochemical verification [either expired CO breath test reading of < 5 ppm using the Belfont Micro+® Smokerlyzer test, or of < 6 ppm if using the iCOquit® Smokerlyzer test, or a cotinine level of less than or equal to 30 ng/ml if using an Alere iScreen saliva test]. If the participant does not meet both criteria, they are not considered abstinent.
At 12 weeks from Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average frequency of app use
Time Frame: Weeks 0-24

Average frequency of app use over the 24-week study period. Measured by average number of app openings.
Weeks 0-24
Average duration of app use
Time Frame: Weeks 0-24

Average duration of app use over the 24-week study period.
Weeks 0-24
Average number of app modules completed
Time Frame: Weeks 0-24

Average number of app modules completed over the 24-week study period.
Weeks 0-24
Average app usability scores
Time Frame: At 4 weeks from baseline

Average self-reported scores of usability on the 10-item System Usability Scale. Scores range from 0-100 with higher scores indicating higher usability of the app.
At 4 weeks from baseline
Average user experience scores
Time Frame: At 4 weeks from baseline

Average self-reported scores of user experience using the User Experience Questionnaire - Short Version.
At 4 weeks from baseline
Average user experience scores
Time Frame: At 12 weeks from baseline

Average self-reported scores of user experience using the User Experience Questionnaire - Short Version.
At 12 weeks from baseline
Average user experience scores
Time Frame: At 24 weeks from baseline

Average self-reported scores of user experience using the User Experience Questionnaire - Short Version.
At 24 weeks from baseline
Average acceptance of physical smoking cravings
Time Frame: At 4 weeks from baseline

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
At 4 weeks from baseline
Average acceptance of physical smoking cravings
Time Frame: At 12 weeks from baseline

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
At 12 weeks from baseline
Average acceptance of physical smoking cravings
Time Frame: At 24 weeks from baseline

Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
At 24 weeks from baseline
Nicotine patch use
Time Frame: At 12 weeks from baseline

Average number of days (out of 56 possible) per arm that participants used the nicotine patch.
At 12 weeks from baseline
Nicotine gum use
Time Frame: At 12 weeks from baseline

Average number of nicotine gum used per arm.
At 12 weeks from baseline
Smoking Costs at 4 Weeks
Time Frame: At 4 weeks from baseline

Average costs of smoking per group as measured by the Smoking Costs Questionnaire
At 4 weeks from baseline
Smoking Costs at 12 Weeks
Time Frame: At 12 weeks from baseline

Average costs of smoking per group as measured by the Smoking Costs Questionnaire
At 12 weeks from baseline
Smoking Costs at 24 Weeks
Time Frame: At 24 weeks from baseline

Average costs of smoking per group as measured by the Smoking Costs Questionnaire
At 24 weeks from baseline
Costs of technical coaching
Time Frame: At 24 weeks from baseline

Cost of technical coaching calls estimated by number of technical coaching calls to assist with the use of the QoG DTx
At 24 weeks from baseline
Experiences of racism at week 4
Time Frame: At 4 weeks from baseline

Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale
At 4 weeks from baseline
Experiences of racism at week 12
Time Frame: At 12 weeks from baseline

Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale
At 12 weeks from baseline
Experiences of racism at week 24
Time Frame: At 24 weeks from baseline

Self-reported experiences of racism per group as measured by the Everyday Discrimination Scale
At 24 weeks from baseline
Quality of Life at week 4
Time Frame: At 4 weeks from baseline

Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF
At 4 weeks from baseline
Quality of Life at week 12
Time Frame: At 12 weeks from baseline

Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF
At 12 weeks from baseline
Quality of Life at week 24
Time Frame: At 24 weeks from baseline

Self-reported quality of life per group as measured by the World Health Organization Quality of Life Scale - BREF
At 24 weeks from baseline
Frequency of e-cigarette use at Week 4
Time Frame: At 4 weeks from baseline

Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview
At 4 weeks from baseline
Frequency of e-cigarette use at Week 12
Time Frame: At 12 weeks from baseline

Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview
At 12 weeks from baseline
Frequency of e-cigarette use at Week 24
Time Frame: At 24 weeks from baseline

Average number of days of e-cigarette use per group as measured by a Timeline Follow Back Interview
At 24 weeks from baseline
Frequency of use of other tobacco products at week 4
Time Frame: At 4 weeks from baseline

Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview.
At 4 weeks from baseline
Frequency of use of other tobacco products at week 12
Time Frame: At 12 weeks from baseline

Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview.
At 12 weeks from baseline
Frequency of use of other tobacco products at week 24
Time Frame: At 24 weeks from baseline

Average number of days of use of other tobacco products per group as measured by a Timeline Follow Back Interview.
At 24 weeks from baseline
Frequency of use of cannabis at week 4
Time Frame: At 4 weeks from baseline

Average number of days of cannabis per group as measured by a Timeline Follow Back Interview.
At 4 weeks from baseline
Frequency of use of cannabis at week 12
Time Frame: At 12 weeks from baseline

Average number of days of cannabis per group as measured by a Timeline Follow Back Interview.
At 12 weeks from baseline
Frequency of use of cannabis at week 24
Time Frame: At 24 weeks from baseline

Average number of days of cannabis per group as measured by a Timeline Follow Back Interview.
At 24 weeks from baseline
Frequency of use of alcohol at week 4
Time Frame: At 4 weeks from baseline

Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview.
At 4 weeks from baseline
Frequency of use of alcohol at week 12
Time Frame: At 12 weeks from baseline

Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview.
At 12 weeks from baseline
Frequency of use of alcohol at week 24
Time Frame: At 24 weeks from baseline

Average number of days of alcohol use per group as measured by a Timeline Follow Back Interview.
At 24 weeks from baseline

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.
Wake Forest University Health Sciences

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)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roger Vilardaga, PhD, Wake Forest University

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.
September 21, 2021

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.
December 30, 2025

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.
December 30, 2025

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).
August 26, 2021

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.
August 26, 2021

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.
September 1, 2021

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 9, 2026

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.
November 4, 2026

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.
July 1, 2025

More Information

Terms related to this study

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.
  • IRB00110770
  • R01DA047301 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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