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Supporting Treatment Access and Recovery in Opioid Use and Mental Health Disorders

This study is for people aged 18 and older who have both opioid use disorder (OUD) and a mental health disorder. It's testing a team-based approach called MISSION, which includes medication management, intensive community services, peer support, and structured therapy sessions. You might be eligible if you are newly admitted to a program for OUD or have recently relapsed while on medications like buprenorphine or naltrexone. The study aims to see if adding MISSION, or parts of it, to your current medication for opioid use disorder (MOUD) helps you stay engaged in treatment and improve your substance use and mental health. We'll measure how well you engage in treatment and MOUD after 6 months.

Study design
This is a randomized control trial with 1,000 participants across Massachusetts. You would be assigned to one of five groups, some receiving MOUD alone and others receiving MOUD plus different combinations of the MISSION program components.
What's involved
Participants will receive 6 months of treatment, which may include medication management, intensive community-based services, 11 recovery-oriented peer support sessions, and 13 structured therapy sessions.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 year after starting treatment, with key measurements taken at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05138614

Supporting Treatment Access and Recovery in COD

Recruiting
NAAges 18+InterventionalTreatment
University of Massachusetts, Worcester
~1,000 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Medication for Opioid Use DisorderMISSION Critical Time InterventionMISSION Peer SupportMISSION Dual Recovery Therapy

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Engagement in treatment
Measured over 6 months
+57 more outcomes measured

Conditions

Opioid Use Disorder
Mental Health Disorder

Explore related trials

Opioid Use DisorderPsychiatric Disorder

Where it's being run

5 sites across 1 states
Massachusetts5

Study leadership

  • David Smelson, PsyD · PRINCIPAL_INVESTIGATOR · University of Massachusetts, Worcester

Who to contact

David Smelson, PsyD
[email protected]
508-713-5420
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Are 18 years-old and older;
Are fluent in English or Spanish;
Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.;
Able to provide consent;
Potentially have a concurrent substance use disorder in addition to opioids; and

Exclusion

Are not fluent in English or Spanish;
Are acutely psychotic, acutely suicidal with a plan, or homicidal;
Are incompetent and unable to provide informed consent; and

What this trial measures

  • Engagement in treatment6 months

    Measured by total days in treatment

  • Engagement in medication for opioid use disorder (MOUD)6 months

    Measured by percentage of days receiving MOUD

  • Engagement in outreach and linkage sessions6 months

    Measured by total number of outreach and linkage sessions

  • Self-report opioid use and other substance useBaseline

    Measured by self-report days of use

  • Self-report opioid use and other substance use3 months

    Measured by self-report days of use

  • Self-report opioid use and other substance use6 months

    Measured by self-report days of use

  • Self-report opioid use and other substance use9 months

    Measured by self-report days of use

  • Self-report opioid use and other substance use12 months

    Measured by self-report days of use

  • Opioid use and other substance use (drug screen)3 months

    Measured by positive drug screens

  • Opioid use and other substance use (drug screen)6 months

    Measured by positive drug screens

  • Mental health functioningBaseline

    Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)

  • Mental health functioning3 months

    Measured by self-report mental health symptoms on BASIS-24

  • Mental health functioning6 months

    Measured by self-report mental health symptoms on BASIS-24

  • Mental health functioning9 months

    Measured by self-report mental health symptoms on BASIS-24

  • Mental health functioning12 months

    Measured by self-report mental health symptoms on BASIS-24

  • PTSD symptomsBaseline

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  • PTSD symptoms3 months

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  • PTSD symptoms6 months

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  • PTSD symptoms9 months

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  • PTSD symptoms12 months

    Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)

  • Mental health impairmentBaseline

    Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)

  • Mental health impairment3 months

    Measured by self-report on WHODAS 2.0

  • Mental health impairment6 months

    Measured by self-report on WHODAS 2.0

  • Mental health impairment9 months

    Measured by self-report on WHODAS 2.0

  • Mental health impairment12 months

    Measured by self-report on WHODAS 2.0

  • Psychiatric severityBaseline

    Measured by Structured Clinical Interview for DSM-5 (SCID-RV)

  • Health functioningBaseline

    Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)

  • Health functioning3 months

    Measured by the WHOQOL-BREF

  • Health functioning6 months

    Measured by the WHOQOL-BREF

  • Health functioning9 months

    Measured by the WHOQOL-BREF

  • Health functioning12 months

    Measured by the WHOQOL-BREF

  • Motivation for treatmentBaseline

    Measured by Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES)

  • Motivation for treatment3 months

    Measured by SOCRATES

  • Motivation for treatment6 months

    Measured by SOCRATES

  • Motivation for treatment9 months

    Measured by SOCRATES

  • Motivation for treatment12 months

    Measured by SOCRATES

  • Suicide SeverityBaseline

    Measured by Columbia- Suicide Severity Rating Scale (C-SSRS)

  • Suicide Severity3 months

    Measured by C-SSRS

  • Suicide Severity6 months

    Measured by C-SSRS

  • Suicide Severity9 months

    Measured by C-SSRS

  • Suicide Severity12 months

    Measured by C-SSRS

  • Therapeutic allianceBaseline

    Measured by Working Alliance Inventory

  • Therapeutic alliance3 months

    Measured by Working Alliance Inventory

  • Therapeutic alliance6 months

    Measured by Working Alliance Inventory

  • Therapeutic alliance9 months

    Measured by Working Alliance Inventory

  • Therapeutic alliance12 months

    Measured by Working Alliance Inventory

  • Recovery CapitalBaseline

    Measured by Assessment of Recovery Capital

  • Recovery Capital3 months

    Measured by Assessment of Recovery Capital

  • Recovery Capital6 months

    Measured by Assessment of Recovery Capital

  • Recovery Capital9 months

    Measured by Assessment of Recovery Capital

  • Recovery Capital12 months

    Measured by Assessment of Recovery Capital

  • Chronic painBaseline

    Measured by Chronic Pain assessment

  • Chronic pain3 months

    Measured by Chronic Pain assessment

  • Chronic pain6 months

    Measured by Chronic Pain assessment

  • Chronic pain9 months

    Measured by Chronic Pain assessment

  • Chronic pain12 months

    Measured by Chronic Pain assessment

  • Medication Adherence3 months

    Measured by Medication Adherence Rating Scale

  • Medication Adherence6 months

    Measured by Medication Adherence Rating Scale