The STop UNhealthy Substance Use Now Trial (STUN II)

March 24, 2026 updated by: Dan.Jonas, Ohio State University
The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices

Specific aim 1 (primary aim) will compare the effect of learning collaborative (LC) participation, performance incentives (PI), or their combination, with practice facilitation (PF) only, on implementation of evidence-based screening for SUDs.

Specific aim 2 (secondary aim) will compare the effect of LC participation, PI, or their combination, with PF only, on implementation of evidence-based interventions for SUDs, including (a) brief counseling, (b) medications (e.g., buprenorphine, naltrexone) and adherence to them, and (c) referral to specialty care.

Specific aims 1 and 2 will produce fundamentally important evidence about the comparative effectiveness of PF, PF+LC, PF+PI, and PF+LC+PI strategies on uptake of evidence-based screening and interventions for SUD when delivered to primary care practices.

Specific aim 3 (exploratory aim) will use a longitudinal mixed-methods evaluation to assess the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate). Aim 3 will generate scientific knowledge about mechanisms of change (why and how the various strategies work) in primary care settings.

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 (Estimated)

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.
144

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45237
        • Bon Secours Mercy Health
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
      • Columbus, Ohio, United States, 43215
        • Ohio Association of Community Health Centers

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Clinic staff members from primary care practices who provide care for adult patients and have a leadership role within the practice (e.g. lead physician, practice manager, lead medical assistant/nurse, clinical champion)

Exclusion Criteria:

  • Clinic staff members who already have ongoing involvement in programs that would conflict with or preclude this study

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial 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.
Active Comparator: Practice Facilitation Only
Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.
Other: Practice Facilitation (PF)
Practices will meet with practice facilitators monthly and apply tests of change using a Plan-Do-Study-Act approach, guided by the PF team. Facilitators will confirm that practices have established workflows for substance use disorder (SUD) screening and interventions and perform checks periodically to ensure progression. PF will entail: implementing protocols/algorithms for evidence-based screening and interventions, promoting decision support tools and templates to support practice workflow, optimizing electronic health record (EHR) use to pull clinical data monthly to guide the improvement process, developing patient registries (e.g., for those with SUD) to identify needed care and optimize delivery of evidence-based interventions, encouraging proactive, team-based care with assigned roles and responsibilities, and enhancing the understanding of evidence-based SUD interventions, including counseling and referral resources to ensure practices have appropriate intervention options.
Experimental: Practice Facilitation + Learning Collaborative

Practice Facilitation (PF): Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.

Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q&A.
Other: Practice Facilitation (PF)
Practices will meet with practice facilitators monthly and apply tests of change using a Plan-Do-Study-Act approach, guided by the PF team. Facilitators will confirm that practices have established workflows for substance use disorder (SUD) screening and interventions and perform checks periodically to ensure progression. PF will entail: implementing protocols/algorithms for evidence-based screening and interventions, promoting decision support tools and templates to support practice workflow, optimizing electronic health record (EHR) use to pull clinical data monthly to guide the improvement process, developing patient registries (e.g., for those with SUD) to identify needed care and optimize delivery of evidence-based interventions, encouraging proactive, team-based care with assigned roles and responsibilities, and enhancing the understanding of evidence-based SUD interventions, including counseling and referral resources to ensure practices have appropriate intervention options.
Other: Learning Collaborative (LC)
Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q&A. Participant-generated ideas for topics to be covered during virtual LC sessions will be encouraged. Some specific topics will include optimal SUD screening approaches; prescribing medications for opioid use disorder (OUD) in primary care; pragmatic issues around integrated SUD care within primary care such as compliance with state and federal requirements, note templates/visit frequency, and when/how to escalate care for patients with severe or worsening SUD; medications for alcohol use disorder (AUD); and motivational interviewing.
Experimental: Practice Facilitation + Performance Incentives

Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.

Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter.
Other: Practice Facilitation (PF)
Practices will meet with practice facilitators monthly and apply tests of change using a Plan-Do-Study-Act approach, guided by the PF team. Facilitators will confirm that practices have established workflows for substance use disorder (SUD) screening and interventions and perform checks periodically to ensure progression. PF will entail: implementing protocols/algorithms for evidence-based screening and interventions, promoting decision support tools and templates to support practice workflow, optimizing electronic health record (EHR) use to pull clinical data monthly to guide the improvement process, developing patient registries (e.g., for those with SUD) to identify needed care and optimize delivery of evidence-based interventions, encouraging proactive, team-based care with assigned roles and responsibilities, and enhancing the understanding of evidence-based SUD interventions, including counseling and referral resources to ensure practices have appropriate intervention options.
Other: Performance Incentives (PI)
We will work closely with key stakeholders and the Steering Committee to co-design the PI strategy, refining the specific performance metrics to ensure that they align with other ongoing efforts in our partnering organizations. We plan to base the incentive on achieving a threshold target for the percentage of eligible adult patients screened for SUD, or the percentage improvement in screening, for quarters 1 and 2. For quarters 3 and 4, after practices have had time to implement and improve their processes for screening for SUD, the incentives will evolve to become a composite of (1) patients screened for SUD (the same as used in quarters 1 and 2) and (2) achieving a threshold target for the percentage of persons with SUD who received evidence-based interventions.
Experimental: Practice Facilitation + Learning Collaborative + Performance Incentives

Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.

Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q&A.

Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter.
Other: Practice Facilitation (PF)
Practices will meet with practice facilitators monthly and apply tests of change using a Plan-Do-Study-Act approach, guided by the PF team. Facilitators will confirm that practices have established workflows for substance use disorder (SUD) screening and interventions and perform checks periodically to ensure progression. PF will entail: implementing protocols/algorithms for evidence-based screening and interventions, promoting decision support tools and templates to support practice workflow, optimizing electronic health record (EHR) use to pull clinical data monthly to guide the improvement process, developing patient registries (e.g., for those with SUD) to identify needed care and optimize delivery of evidence-based interventions, encouraging proactive, team-based care with assigned roles and responsibilities, and enhancing the understanding of evidence-based SUD interventions, including counseling and referral resources to ensure practices have appropriate intervention options.
Other: Learning Collaborative (LC)
Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q&A. Participant-generated ideas for topics to be covered during virtual LC sessions will be encouraged. Some specific topics will include optimal SUD screening approaches; prescribing medications for opioid use disorder (OUD) in primary care; pragmatic issues around integrated SUD care within primary care such as compliance with state and federal requirements, note templates/visit frequency, and when/how to escalate care for patients with severe or worsening SUD; medications for alcohol use disorder (AUD); and motivational interviewing.
Other: Performance Incentives (PI)
We will work closely with key stakeholders and the Steering Committee to co-design the PI strategy, refining the specific performance metrics to ensure that they align with other ongoing efforts in our partnering organizations. We plan to base the incentive on achieving a threshold target for the percentage of eligible adult patients screened for SUD, or the percentage improvement in screening, for quarters 1 and 2. For quarters 3 and 4, after practices have had time to implement and improve their processes for screening for SUD, the incentives will evolve to become a composite of (1) patients screened for SUD (the same as used in quarters 1 and 2) and (2) achieving a threshold target for the percentage of persons with SUD who received evidence-based interventions.

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
Number of adults screened for substance use disorder
Time Frame: 12 months
Number of people aged 18 and older who are screened for substance use disorder using a validated screening tool
12 months
Percent of adults screened for substance use disorder
Time Frame: 12 months
Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool
12 months

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
Number of adults with a positive screen for substance use disorder
Time Frame: 12 months
Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result
12 months
Number of adults with a positive screen for substance use disorder
Time Frame: 24 months
Of those aged 18 and older who were screened for substance use disorder, number who had a positive screening result
24 months
Percent of adults with a positive screen for substance use disorder
Time Frame: 12 months
Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result
12 months
Percent of adults with a positive screen for substance use disorder
Time Frame: 24 months
Of those aged 18 and older who were screened for substance use disorder, percentage who had a positive screening result
24 months
Number of adults who received any evidence-based intervention for substance use disorder
Time Frame: 12 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who received brief counseling, medication, or referral to specialty care
12 months
Number of adults who received any evidence-based intervention for substance use disorder
Time Frame: 24 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who received brief counseling, medication, or referral to specialty care
24 months
Percentage of adults who received any evidence-based intervention for substance use disorder
Time Frame: 24 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage that received brief counseling, medication, or referral to specialty care
24 months
Percentage of adults who received any evidence-based intervention for substance use disorder
Time Frame: 12 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage that received brief counseling, medication, or referral to specialty care
12 months
Number of adults who received brief counseling for substance use disorder
Time Frame: 12 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling
12 months
Number of adults who received brief counseling for substance use disorder
Time Frame: 24 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received brief counseling
24 months
Percentage of adults who received brief counseling for substance use disorder
Time Frame: 24 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling
24 months
Percentage of adults who received brief counseling for substance use disorder
Time Frame: 12 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received brief counseling
12 months
Number of adults who received medication for substance use disorder
Time Frame: 12 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication
12 months
Number of adults who received medication for substance use disorder
Time Frame: 24 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, number who received medication
24 months
Percentage of adults who received medication for substance use disorder
Time Frame: 24 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication
24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder
Time Frame: 12 months
Of people aged 18 or older who screened positive for substance use disorder and/or alcohol use disorder, percentage who received medication
12 months
Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time Frame: 12 months
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, number who adhered to treatment for 6 months
12 months
Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time Frame: 24 months
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, number who adhered to treatment for 6 months
24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time Frame: 24 months
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, percentage who adhered to treatment for 6 months
24 months
Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment
Time Frame: 12 months
Of those aged 18 or older who received medication for substance use disorder and/or alcohol use disorder, percentage who adhered to treatment for 6 months
12 months
Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
12 months
Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
24 months
Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
24 months
Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older who were identified as having substance use disorder and/or alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
12 months
Number of adults with alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder
12 months
Number of adults with alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older who were screened for substance use disorder, number who had alcohol use disorder
24 months
Percentage of adults with alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder
24 months
Percentage of adults with alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older who were screened for substance use disorder, percentage who had alcohol use disorder
12 months
Number of adults who received any evidence-based intervention for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older identified as having alcohol use disorder, number who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
12 months
Number of adults who received any evidence-based intervention for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older identified as having alcohol use disorder, number who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
24 months
Percentage of adults who received any evidence-based intervention for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older identified as having alcohol use disorder, percentage who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
24 months
Percentage of adults who received any evidence-based intervention for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older identified as having alcohol use disorder, percentage who received any evidence-based intervention (brief counseling, medication, referral to specialty care)
12 months
Number of adults who received brief counseling for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling
12 months
Number of adults who received brief counseling for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older identified as having alcohol use disorder, number who received brief counseling
24 months
Percentage of adults who received brief counseling for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling
24 months
Percentage of adults who received brief counseling for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older identified as having alcohol use disorder, percentage who received brief counseling
12 months
Number of adults who received medication for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older identified as having alcohol use disorder, number who received medication
12 months
Number of adults who received medication for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older identified as having alcohol use disorder, number who received medication
24 months
Percentage of adults who received medication for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication
24 months
Percentage of adults who received medication for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older identified as having alcohol use disorder, percentage who received medication
12 months
Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Time Frame: 12 months
Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months
12 months
Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Time Frame: 24 months
Of those aged 18 or older who received medication for alcohol use disorder, number who adhered to treatment for 6 months
24 months
Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Time Frame: 24 months
Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months
24 months
Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment
Time Frame: 12 months
Of those aged 18 or older who received medication for alcohol use disorder, percentage who adhered to treatment for 6 months
12 months
Number of adults referred to specialty care for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older who were identified as having alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
12 months
Number of adults referred to specialty care for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older who were identified as having alcohol use disorder, number who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
24 months
Percentage of adults referred to specialty care for alcohol use disorder
Time Frame: 24 months
Of those aged 18 or older who were identified as having alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
24 months
Percentage of adults referred to specialty care for alcohol use disorder
Time Frame: 12 months
Of those aged 18 or older who were identified as having alcohol use disorder, percentage who were referred to specialty care (psychiatry, 12-step programs, counseling, etc.)
12 months
Number of adults screened for substance use disorder
Time Frame: 24 months
Number of people aged 18 and older who are screened for substance use disorder using a validated screening tool
24 months
Percent of adults screened for substance use disorder
Time Frame: 24 months
Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool
24 months

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
Association between implementation effectiveness and putative moderators and mediators
Time Frame: 12 months
Longitudinal mixed-methods evaluation (surveys, interviews) to describe the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate)
12 months
Association between implementation effectiveness and putative moderators and mediators
Time Frame: 24 months
Longitudinal mixed-methods evaluation (surveys, interviews) to describe the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate)
24 months

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.
Ohio State 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.
Agency for Healthcare Research and Quality (AHRQ)
Ohio Association of Community Health Centers (OACHC)
Bon Secours Mercy Health (BSMH)

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: Daniel E Jonas, MD, MPH, Ohio State University

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.
September 16, 2024

Primary Completion (Estimated)

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.
September 1, 2027

Study Completion (Estimated)

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.
September 1, 2027

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).
July 23, 2024

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.
July 23, 2024

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.
July 29, 2024

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.
March 25, 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.
March 24, 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.
March 1, 2026

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.
  • 1R18HS029782-01 (U.S. AHRQ 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

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.

Clinical Trials on Substance Use

Clinical Trials on Practice Facilitation (PF)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings