Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05138614

Supporting Treatment Access and Recovery in COD

Led by University of Massachusetts, Worcester · Updated on 2025-06-05

1000

Participants Needed

5

Research Sites

233 weeks

Total Duration

On this page

Sponsors

U

University of Massachusetts, Worcester

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

CONDITIONS

Official Title

Supporting Treatment Access and Recovery in COD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Are 18 years-old and older
  • Are fluent in English or Spanish
  • Have opioid use disorder and are either newly admitted to the program with OUD or have been active on medications like buprenorphine or naltrexone but experienced a recent relapse with any substance
  • Able to provide consent
  • May have a concurrent substance use disorder in addition to opioids
  • Have a co-occurring mental health disorder including depression, anxiety, trauma-related disorders, bipolar disorder, or schizophrenia, or have worsening symptoms of these disorders even without relapse
Not Eligible

You will not qualify if you...

  • 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
  • Have severe alcohol use disorder or high dose benzodiazepine use needing detoxification, including history of severe alcohol withdrawal or seizures
  • High dose benzodiazepine use defined as Lorazepam > 10 mg/day, Diazepam > 100 mg/day, Clonazepam > 5 mg/day, or Alprazolam > 5 mg/day

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Behavioral Health Network

Holyoke, Massachusetts, United States, 01040

Actively Recruiting

2

Behavioral Health Network

Orange, Massachusetts, United States, 01364

Actively Recruiting

3

Behavioral Health Network

Springfield, Massachusetts, United States, 01104

Actively Recruiting

4

UMass Chan Road to Care Clinic

Worcester, Massachusetts, United States, 01601

Actively Recruiting

5

SaVida Health

Worcester, Massachusetts, United States, 01605

Actively Recruiting

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Research Team

D

David Smelson, PsyD

CONTACT

A

Abigail Helm, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

5

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