Supporting Treatment Access and Recovery in COD

Launched by UNIVERSITY OF MASSACHUSETTS, WORCESTER · Nov 16, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach called MISSION to help people who have both opioid use disorder (OUD) and mental health disorders, which is sometimes referred to as co-occurring disorders (COD). Over four years, the trial will include 1,000 participants who are receiving medication for OUD at treatment clinics. The researchers want to find out if adding the MISSION approach, which involves a team of professionals working together, will lead to better results compared to just using medication alone. They hope that participants who receive MISSION, along with their medication, will see improvements in their engagement with treatment, reduced substance use, and better mental health.

To qualify for the study, participants must be at least 18 years old, speak either English or Spanish, and be experiencing issues with both opioid use and mental health. This could include individuals who are new to treatment or those who have had a relapse after being stable for a while. Participants will be asked to consent to join the study and will receive support designed to help them recover. It’s important to note that individuals with severe alcohol use problems or those in acute mental health crises may not be eligible to participate. Overall, this trial aims to provide valuable insights into improving treatment outcomes for those facing the challenges of both substance use and mental health issues.

Gender

ALL

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.