Health TrialsbyHealthPanel

Supporting Treatment Access and Recovery in COD

ConditionsOpioid Use DisorderMental Health Disorder
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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • Medication for Opioid Use Disorder

    Other intervention

    medication management

  • MISSION Critical Time Intervention

    Behavioral

    offering intensive community-based services that decrease in intensity over time

  • MISSION Peer Support

    Behavioral

    including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders

  • MISSION Dual Recovery Therapy

    Behavioral

    comprised of 13 structured co-occurring disorders treatment sessions

Treatment groups

1,000 Participants
are divided into 5 treatment groups
Group A: Full MISSIONExperimental treatment 4 interventions
Group B: CTI & DRTExperimental treatment 3 interventions
Group C: CTI & PSExperimental treatment 3 interventions
Group D: DRT & PSExperimental treatment 3 interventions
Group E: MOUD onlyOther 1 intervention

Trial outcomes

Primary outcomes

1

Engagement in treatment

Measured by total days in treatment

Time frame
6 months
2

Engagement in medication for opioid use disorder (MOUD)

Measured by percentage of days receiving MOUD

Time frame
6 months
3

Engagement in outreach and linkage sessions

Measured by total number of outreach and linkage sessions

Time frame
6 months
4

Self-report opioid use and other substance use

Measured by self-report days of use

Time frame
Baseline

Secondary outcomes

1

Mortality

Data extracted from medical records

Time frame
6 months
2

Quality Adjusted Life Years (QALYs): health

Measured by self-report on the 5-level EQ-5D (EQ-5D-5L). Scores range from 0 (worst imaginable health) to 100 (best imaginable health).

Time frame
Baseline
3

Quality Adjusted Life Years (QALYs): health

Measured by self-report on the 5-level EQ-5D (EQ-5D-5L). Scores range from 0 (worst imaginable health) to 100 (best imaginable health).

Time frame
3 months
4

Quality Adjusted Life Years (QALYs): health

Measured by self-report on the 5-level EQ-5D (EQ-5D-5L). Scores range from 0 (worst imaginable health) to 100 (best imaginable health).

Time frame
6 months

Other outcomes

1

Economic impact of full MISSION

Cost of full MISSION and MOUD measured by Patient-Reported Outcomes Measurement Information System-Preference (PROPr)

Time frame
6 months
2

Economic impact of CTI & PS

Cost of MISSION CTI, PS, and MOUD measured by PROPr

Time frame
6 months
3

Economic impact of CTI & DRT

Cost of MISSION CTI, DRT, and MOUD measured by PROPr

Time frame
6 months
4

Economic impact of PS & DRT

Cost of MISSION PS, DRT, and MOUD measured by PROPr

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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