Supporting Treatment Access and Recovery Through Linkage and Support (STAR-LS)

April 6, 2026 updated by: David Smelson, University of Massachusetts, Worcester

Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services

This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.

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

Addiction is a growing public health problem in the United States (U.S.), with nearly 21 million Americans meeting criteria for substance use disorder (SUD), 1.6 million meeting criteria for opioid use disorder (OUD), and opioid-related overdoses have increased by 50% over the past 5 years. Among people with SUD, 49% have comorbid mental health disorders (COD). Individuals with COD are vulnerable to substance use relapses, mental illness exacerbations, overdoses, homelessness, and criminal justice involvement. However, despite the high rates of morbidity, mortality, and broad social determinant of health needs among people with COD, only 8% of individuals in the U.S. received treatment for both mental illness and SUD. Among those with a COD receiving treatment, 6-month engagement rates are as low as 16% for psychosocial treatments, and 90% of individuals leaving treatment will relapse within 12 weeks. Massachusetts is also hard hit, with a 16% higher SUD prevalence compared to the U.S., and Worcester, the second largest city in Massachusetts, is disproportionately affected by SUD, having one of the highest overdose rates in the state and is ranked 2nd on the Center for Disease Control and Prevention's social vulnerability index. These findings highlight the need to improve treatment access and engagement to support recovery in Worcester, Massachusetts. Both linkage and multicomponent wraparound models have gained popularity as a solution to increase treatment access and engagement. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a hybrid multicomponent linkage and treatment approach, providing assertive outreach linkage support combined with psychosocial treatment, delivered by a cross disciplinary team. MISSION is aligned with the Social Ecological Model (SEM) to address multilevel client needs via 3 evidence-based practices. They include 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated group therapy for COD; and 3) Peer Support (PS), offering support for people in recovery by people in recovery. In response to Funding Opportunity Announcement (RFA-CE-22-010), the proposed 3-year Hybrid Type I study, "Supporting Treatment Access and Recovery through Linkage and Support (STAR-LS)," will recruit and randomize 208 patients with COD in Worcester, MA in the Hub, a program run by the Worcester Health and Human Services to one of the following conditions: 1) MISSION; or 2) Peer Support (linkage only). There are three specific aims: Aim 1: To evaluate the effectiveness of MISSION or compared to Peer Support to improve engagement, substance use and mental health symptoms. Aim 2: To examine mechanisms of action of the interventions. Aim 3: To conduct a sequential mixed methods process evaluation to inform sustainability and future implementation. This proposal is aligned with CDC's Strategic Priority Areas and Health People 2030 Core Objectives as it intends to improve behavioral health outcomes strengthen and sustain the recovery ecosystem for people with COD.

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.
208

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
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

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

Description

Inclusion Criteria:

  • Are 18 or older;
  • Have a COD (1 or more substance use disorders (e.g., alcohol and illicit substances), and a mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia);
  • Are in the Hub; and
  • Are not engaged in other ongoing multi-component treatment for COD with a behavioral health treatment provider or have not seen their provider for at least 3 months.

Exclusion Criteria:

  • We will exclude individuals who are acutely psychotic, acutely suicidal with a plan, or homicidal
  • Or with concurrent severe alcohol use disorder or high dose benzodiazepine requiring detoxification.

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: Full MISSION
Participants assigned to this condition will receive full MISSION services. MISSION services include 6-months of integrated mental health and substance use treatment and treatment planning with the MISSION Case Manager (13 session curriculum) and Peer Support Specialist (11 session curriculum). Content of these sessions will be directed using the MISSION Treatment Manual and Consumer Workbooks. MISSION teams will also provide linkages and supports to treatment services within the participant's community throughout the duration of the study.
Behavioral: Full MISSION
MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.
Active Comparator: Linkage Only Delivered by a Peer Specialist
Our Linkage only arm delivered by a Peer Specialist will act as the comparison group to the MISSION arm. Participants randomized to the linkage only arm will receive 6-months of linkage care from a Peer Specialist. The Peer Specialist will provide informal treatment planning as well as linkages and support to community services, but will not provide integrated dual disorders treatment, nor will this arm utilize any MISSION materials or offer Peer led groups.
Behavioral: Linkage Only Delivered by a Peer Specialist
Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.

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
Self-report opioid use and other substance use
Time Frame: Baseline
Measured by self-report days of use using the Time-line Follow Back (TLFB)
Baseline
Self-report opioid use and other substance use
Time Frame: 3-months
Measured by self-report days of use using the Time-line Follow Back (TLFB)
3-months
Self-report opioid use and other substance use
Time Frame: 6-months
Measured by self-report days of use using the Time-line Follow Back (TLFB)
6-months
Self-report opioid use and other substance use
Time Frame: 9-months
Measured by self-report days of use using the Time-line Follow Back (TLFB)
9-months
Mental Health Functioning
Time Frame: Baseline
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
Baseline
Mental Health Functioning
Time Frame: 3-months
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
3-months
Mental Health Functioning
Time Frame: 6-months
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
6-months
Mental Health Functioning
Time Frame: 9-months
Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)
9-months
PTSD Symptoms
Time Frame: Baseline
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
Baseline
PTSD Symptoms
Time Frame: 3-months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
3-months
PTSD Symptoms
Time Frame: 6-months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
6-months
PTSD Symptoms
Time Frame: 9-months
Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)
9-months
Mental Health Impairment
Time Frame: Baseline
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
Baseline
Mental Health Impairment
Time Frame: 3-months
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
3-months
Mental Health Impairment
Time Frame: 6-months
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
6-months
Mental Health Impairment
Time Frame: 9-months
Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)
9-months
Health functioning
Time Frame: Baseline
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Baseline
Health functioning
Time Frame: 3-months
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
3-months
Health functioning
Time Frame: 6-months
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
6-months
Health functioning
Time Frame: 9-months
Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
9-months
Therapeutic Alliance Client
Time Frame: Baseline
Measured by Working Alliance Inventory-C
Baseline
Therapeutic Alliance Client
Time Frame: 3-months
Measured by Working Alliance Inventory-C
3-months
Therapeutic Alliance Client
Time Frame: 6-months
Measured by Working Alliance Inventory-C
6-months
Therapeutic Alliance Client
Time Frame: 9-months
Measured by Working Alliance Inventory-C
9-months
Therapeutic Alliance Therapist
Time Frame: Baseline
Measured by Working Alliance Inventory-T
Baseline
Therapeutic Alliance Therapist
Time Frame: 3-months
Measured by Working Alliance Inventory-T
3-months
Therapeutic Alliance Therapist
Time Frame: 6-months
Measured by Working Alliance Inventory-T
6-months
Therapeutic Alliance Therapist
Time Frame: 9-months
Measured by Working Alliance Inventory-T
9-months
Recovery Capital
Time Frame: Baseline
Measured by Assessment of Recovery Capital (ARC)
Baseline
Recovery Capital
Time Frame: 3-months
Measured by Assessment of Recovery Capital (ARC)
3-months
Recovery Capital
Time Frame: 6-months
Measured by Assessment of Recovery Capital (ARC)
6-months
Recovery Capital
Time Frame: 9-months
Measured by Assessment of Recovery Capital (ARC)
9-months
Alcohol or other drug 12-Step Participation
Time Frame: Baseline
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
Baseline
Alcohol or other drug 12-Step Participation
Time Frame: 3-months
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
3-months
Alcohol or other drug 12-Step Participation
Time Frame: 6-months
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
6-months
Alcohol or other drug 12-Step Participation
Time Frame: 9-months
Measured by self-report using the Alcoholics Anonymous Inventory (AAI)
9-months
Overdose Risk
Time Frame: Baseline
Self-report using the Overdose Risk Questionnaire (OdRi)
Baseline
Overdose Risk
Time Frame: 3-months
Self-report using the Overdose Risk Questionnaire (OdRi)
3-months
Overdose Risk
Time Frame: 6-months
Self-report using the Overdose Risk Questionnaire (OdRi)
6-months
Overdose Risk
Time Frame: 9-months
Self-report using the Overdose Risk Questionnaire (OdRi)
9-months
Number of Outreach and Linkage Sessions
Time Frame: Baseline
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
Baseline
Number of Outreach and Linkage Sessions
Time Frame: 3-months
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
3-months
Number of Outreach and Linkage Sessions
Time Frame: 6-months
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
6-months
Number of Outreach and Linkage Sessions
Time Frame: 9-months
Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet
9-months
Baseline Demographics
Time Frame: Baseline
Self-reported using the Addiction Severity Index (ASI)
Baseline
Community Health & Social Needs
Time Frame: Baseline
Self-report using the Accountable Health Communities & Health-Related Social Needs
Baseline
Fidelity to Intervention
Time Frame: Weekly
Measured via clinical staff submitting weekly treatment fidelity logs
Weekly
Acceptability & Appropriateness
Time Frame: 6-months
Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)
6-months
Feasibility of Intervention
Time Frame: 6-months
Using the Feasibility of Intervention Measure (FIM)
6-months
Satisfaction with Care
Time Frame: 6-months
Self-report using the Treatment Satisfaction Questionnaire
6-months
Psychiatric Severity
Time Frame: Screening
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Screening
Psychiatric Severity
Time Frame: Baseline
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
Baseline
Psychiatric Severity
Time Frame: 3-months
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
3-months
Psychiatric Severity
Time Frame: 6-months
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
6-months
Psychiatric Severity
Time Frame: 9-months
Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)
9-months
Suicide Severity
Time Frame: Screening
Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Screening

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.
University of Massachusetts, Worcester

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.
Centers for Disease Control and Prevention
University of Massachusetts, Amherst
University of Massachusetts, Lowell

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: David Smelson, PsyD, University of Massachusetts, Worcester

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 24, 2023

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, 2026

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, 2026

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).
January 27, 2023

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.
January 27, 2023

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.
February 6, 2023

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.
April 13, 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.
April 6, 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.
April 1, 2026

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.
  • STUDY00000749

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Consistent with Health and Human Services/Center for Disease Control and Prevention (CDC) policy, research resources and data will be made readily available for research purposes to qualified individuals within the scientific community after publication of any scholarly work. Scholarly publications will also be immediately available to the public on PubMed Central. Additionally, raw and analyzed de-identified data used in publications will be responsibly shared through submissions to a CDC-approved data repository. Other methods for data sharing will be via presentations at professional conferences and, as findings permit, disclosure of summary data to professionals and the general public. To the extent feasible and appropriate, we will share pre-publication findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings. We expect to further disseminate the study via gray literature and the project website.

IPD Sharing Time Frame

De-identified data will be shared with qualified and approved researchers via an appropriate data repository. Research data will be destroyed 6 years after the end of the Fiscal Year in which the study is completed. The master list of identifiers will be destroyed at the 6-year mark or when all statistical analyses have been completed and scientific papers have been published, whichever comes first.

IPD Sharing Access Criteria

We will share findings with colleagues who have a demonstrable, legitimate scientific interest that may be addressed by research findings.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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