Supporting Treatment Access and Recovery in COD

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder, Mental Health Disorder

In brief

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.

Key facts

Study ID

NCT05138614

Run by

University of Massachusetts, Worcester

People needed

1000

Starts

2022-03-11

Expected to finish

2026-08-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Have a co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, and those who are stable on buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms of any co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, even if the patient has not relapsed. Instability is defined in two ways in the study: (a) a substance use relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental health disorder(s). If subjects do not meet criteria for "a" (i.e., not having a substance use relapse), but they do meet criteria for "b" (i.e., they do in fact have worsening of mental health symptoms), they are then defined as unstable, and will meet study inclusion criteria.

You may not qualify if…

• 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
• Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification. This exclusion factor is based on DSM-5 criteria, and those who are currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol related seizures, and delirium tremens) will also be excluded. High dose benzodiazepine is defined as using Lorazepam equivalent of > 10 mg/day; Diazepam > 100 mg/day; Clonazepam 5 mg/ day; Alprazolam 5 mg/day.

Where it is running

• Behavioral Health Network — Holyoke, Massachusetts, United States (enrolling)
• Behavioral Health Network — Orange, Massachusetts, United States (enrolling)
• Behavioral Health Network — Springfield, Massachusetts, United States (enrolling)
• UMass Chan Road to Care Clinic — Worcester, Massachusetts, United States (enrolling)
• SaVida Health — Worcester, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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