Improving access and recovery for people with opioid use and mental health disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study will evaluate the effectiveness of a multi-component team approach called MISSION, combined with medication for opioid use disorder (MOUD), for individuals with co-occurring opioid use and mental health disorders. A total of 1,000 participants will be randomized into five groups: MOUD alone or various combinations of MISSION components with MOUD. The MISSION approach includes Critical Time Intervention, Dual Recovery Therapy, and Peer Support, all aimed at enhancing treatment engagement and improving mental health outcomes. Participants will receive six months of treatment and be followed for one year to assess the impact on their recovery.

Why it matters

Who can join: the full rules

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 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.

Exclusion Criteria:

* 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's running

• Behavioral Health Network
  Holyoke, Massachusetts, United States Recruiting
• Behavioral Health Network
  Orange, Massachusetts, United States Recruiting
• Behavioral Health Network
  Springfield, Massachusetts, United States Recruiting
• UMass Chan Road to Care Clinic
  Worcester, Massachusetts, United States Recruiting
• SaVida Health
  Worcester, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: David Smelson, PsyD — University of Massachusetts, Worcester
• Study coordinator: David Smelson, PsyD
• Email: David.Smelson@umassmed.edu
• Phone: 508-713-5420

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

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• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.