RecruitingNot Applicable

Supporting Treatment Access and Recovery in COD

United States1,000 participantsStarted 2022-03-11

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 menta…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Engagement in treatment

Timeframe: 6 months

Engagement in medication for opioid use disorder (MOUD)

Timeframe: 6 months

Engagement in outreach and linkage sessions

Timeframe: 6 months

Self-report opioid use and other substance use

Timeframe: Baseline

Self-report opioid use and other substance use

Timeframe: 3 months

Self-report opioid use and other substance use

Timeframe: 6 months

Self-report opioid use and other substance use

Timeframe: 9 months

Self-report opioid use and other substance use

Trial details

NCT IDNCT05138614

SponsorUniversity of Massachusetts, Worcester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

David Smelson, PsyD

508-713-5420 David.Smelson@umassmed.edu

View on ClinicalTrials.gov More Opioid Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Engagement in treatment

Timeframe: 6 months

Engagement in medication for opioid use disorder (MOUD)

Timeframe: 6 months

Engagement in outreach and linkage sessions

Timeframe: 6 months

Self-report opioid use and other substance use

Timeframe: Baseline

Self-report opioid use and other substance use

Timeframe: 3 months

Self-report opioid use and other substance use

Timeframe: 6 months

Self-report opioid use and other substance use

Timeframe: 9 months

Self-report opioid use and other substance use