Supporting Treatment Access and Recovery in COD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Medication for Opioid Use Disorder
- MISSION Critical Time Intervention
- MISSION Peer Support
- MISSION Dual Recovery Therapy
Treatment groups
1,000 Participants
are divided into 5 treatment groupsSponsors and collaborators
University of Massachusetts, Worcester
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
University of Massachusetts, Lowell
Collaborator
Cornell University
Collaborator
Harvard Medical School (HMS and HSDM)
Collaborator
Source ClinicalTrials.gov