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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
STAR-COD Trial 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.Check my eligibility
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.See study design
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.
STAR-COD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chronic pain
Engagement in medication for opioid use disorder (MOUD)
Engagement in outreach and linkage sessions
+14 moreSecondary outcome measures
Mortality
Other outcome measures
Economic impact of CTI & DRT
Economic impact of CTI & PS
Economic impact of MOUD alone
+2 moreSTAR-COD 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
343 Previous Clinical Trials
985,610 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
195 Previous Clinical Trials
1,315,045 Total Patients Enrolled
University of Texas at AustinOTHER
353 Previous Clinical Trials
80,244 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fluent in either English or Spanish.I have opioid use disorder and recently relapsed despite being in a treatment program.I have a stable mental health condition but my symptoms have recently worsened.I am 18 years old or older.I am unable to understand and give consent for medical procedures.I am not fluent in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: CTI & DRT
- Group 2: MOUD only
- Group 3: Full MISSION
- Group 4: DRT & PS
- Group 5: CTI & PS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many medical facilities are currently involved in this clinical trial?
"This clinical trial is running out of 9 separate sites, situated in cities like Pittsfield, Chicopee and Framingham. Participants should consider the site closest to them when choosing which location to enrol at for their convenience."
Answered by AI
Is this experimental protocol recruiting test subjects currently?
"Affirmative. As can be seen on clinicaltrials.gov, this medical experiment is in need of applicants at the moment; it was inaugurated on March 11th 2022 and updated recently as August 22nd 2022. 1000 individuals are being recruited from 9 different sites."
Answered by AI
How many participants are being evaluated in this research?
"Affirmative, the clinicaltrial.gov database reveals that this trial is recruiting patients at present time. Initially published on March 11th 2022, it was most recently revised on August 22nd 2022 and currently seeks 1000 individuals across 9 different sites."
Answered by AI
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