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

Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders

This study is testing a new team approach combined with medication to see if it helps people with both opioid use and mental health issues recover better than just using medication alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Massachusetts, Worcester (Academic / other)
• Locations: 5 sites (Holyoke, Massachusetts and 4 other locations)
• Trial ID: NCT05138614 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with opioid use disorder and a co-occurring mental health disorder, including those newly admitted or those who have recently relapsed.

Not a fit: Patients who do not have a co-occurring mental health disorder or are not fluent in English or Spanish may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment engagement and recovery outcomes for patients with co-occurring disorders.

How similar studies have performed: Other studies have shown success with integrated treatment approaches for co-occurring disorders, suggesting potential for positive outcomes in this trial.

Eligibility criteria

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 this trial is running

Holyoke, Massachusetts and 4 other locations

• 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

Conditions Opioid Use Disorder; Mental Health Disorder; opioid use disorder; mental health