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Team-Based Care for Opioid Use Disorder and Mental Health Disorders (STAR-COD Trial)

N/A
Recruiting
Led By David Smelson, PsyD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Are incompetent and unable to provide informed consent
Are not fluent in English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a team approach to treating people with substance abuse and mental health disorders is more effective than treating them with medication for substance abuse alone.

Who is the study for?
This trial is for adults fluent in English or Spanish with opioid use disorder (OUD) and a co-occurring mental health disorder like depression, anxiety, trauma-related disorders, bipolar, or schizophrenia. Participants can be new to treatment or have relapsed while on medications such as buprenorphine or naltrexone. Excluded are those acutely psychotic/suicidal/homicidal, severely addicted to alcohol needing detoxification, or unable to consent.
What is being tested?
The study tests the MISSION model—a comprehensive care approach—against standard medication treatments for OUD alone. It examines if adding MISSION's therapy and support services improves patient engagement and outcomes in substance use and mental health over just using medications like buprenorphine/naltrexone.
What are the potential side effects?
While specific side effects aren't listed here, interventions may include typical risks associated with behavioral therapies and peer support activities. Medications for OUD could cause nausea, headaches, dizziness among others; however these will vary based on individual conditions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand and give consent for medical procedures.
Select...
I am not fluent in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chronic pain
Engagement in medication for opioid use disorder (MOUD)
Engagement in outreach and linkage sessions
+14 more
Secondary study objectives
Mortality
Other study objectives
Economic impact of CTI & DRT
Economic impact of CTI & PS
Economic impact of MOUD alone
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: MOUD onlyExperimental Treatment1 Intervention
MOUD
Group II: Full MISSIONExperimental Treatment4 Interventions
CTI + DRT + PS + MOUD
Group III: DRT & PSExperimental Treatment3 Interventions
DRT + PS + MOUD
Group IV: CTI & PSExperimental Treatment3 Interventions
CTI + PS + MOUD
Group V: CTI & DRTExperimental Treatment3 Interventions
CTI + DRT + MOUD

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
991,720 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
204 Previous Clinical Trials
1,315,685 Total Patients Enrolled
Cornell UniversityOTHER
173 Previous Clinical Trials
14,088,608 Total Patients Enrolled
University of Texas at AustinOTHER
378 Previous Clinical Trials
85,609 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,750,641 Total Patients Enrolled
University of Massachusetts, LowellOTHER
20 Previous Clinical Trials
9,296 Total Patients Enrolled
David Smelson, PsyDPrincipal InvestigatorUniversity of Massachusetts, Worcester
1 Previous Clinical Trials
208 Total Patients Enrolled

Media Library

MISSION Critical Time Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05138614 — N/A
Opioid Use Disorder Research Study Groups: CTI & DRT, MOUD only, Full MISSION, DRT & PS, CTI & PS
Opioid Use Disorder Clinical Trial 2023: MISSION Critical Time Intervention Highlights & Side Effects. Trial Name: NCT05138614 — N/A
MISSION Critical Time Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05138614 — N/A
~132 spots leftby Jun 2025
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