Clinical trial NCT05138614: Supporting Treatment Access and Recovery in COD
Official title: Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Mental Health Disorder
Keywords: opioid use disorder
mental health
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Massachusetts, Lowell
name: Cornell University
name: Harvard Medical School (HMS and HSDM)
First posted: 2021-12-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices along with MOUD: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a 5-arm randomized control trial with a fractional factorial design among 1,000 patients across Massachusetts. Patients will be randomized to: 1) MOUD alone; 2) full MISSION (CTI \& DRT \& PS) + MOUD; 3) CTI \& DRT + MOUD; 4) PS \& DRT + MOUD; or 5) CTI \& PS + MOUD (Arms 3-5 are the 3 combinations of 2 MISSION parts). MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices along with MOUD: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery. Participants will receive 6 months of treatment and be followed for 1-year.

Study aims include:

Aim 1: To evaluate the effectiveness of MISSION or its bundled parts with MOUD versus MOUD alone, as well as the incremental benefits of MISSION and its parts + MOUD to improve outcomes 1a-c for CODs.

Hypothesis 1.1: Individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: 1a. Engagement (measured by total days in treatment, percentage of days receiving MOUD, and total number of outreach and linkages sessions); 1b. Opioid use and other substance use (measured by self-report days of use and drug screens); and 1c. Mental health (measured by self-report mental health symptoms).

Hypothesis 1.2: MISSION + MOUD will outperform its parts + MOUD but at least one of the three combinations + MOUD will be at least 75% as effective compared to the full MISSION protocol on outcomes 1a-c.

Aim 2: To examine mechanisms of action of MISSION in CODs. Hypothesis 2.1: The effects of MISSION and its bundled parts on health outcomes (mental health, opioid and other substance use) are mediated by treatment participation and other measures (e.g., recovery capital, psychosocial supports, and quality of life). Hypothesis 2.2: The effects of MISSION and its parts on health outcomes are moderated by key patient characteristics (e.g., demographics, severity of COD, and MOUD type).

Aim 3: To conduct a comprehensive economic evaluation of MISSION or its bundled parts and MOUD.

Estimate cost of full MISSION or its bundled parts compared to MOUD alone, and to evaluate cost-effectiveness and return on investment from multiple perspectives, including patient, clinic, healthcare, taxpayer, and societal.

Exploratory Aim: 4. To construct a predictive model that can match optimum combined use of MISSION parts with specific patient's needs for greater improvements in health outcomes, which will inform a future randomized controlled trial on cost-effective patient-level precision intervention assignment.

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.

Primary outcomes:
measure: Engagement in treatment
timeFrame: 6 months
measure: Engagement in medication for opioid use disorder (MOUD)
timeFrame: 6 months
measure: Engagement in outreach and linkage sessions
timeFrame: 6 months
measure: Self-report opioid use and other substance use
timeFrame: Baseline
measure: Self-report opioid use and other substance use
timeFrame: 3 months
measure: Self-report opioid use and other substance use
timeFrame: 6 months
measure: Self-report opioid use and other substance use
timeFrame: 9 months
measure: Self-report opioid use and other substance use
timeFrame: 12 months
measure: Opioid use and other substance use (drug screen)
timeFrame: 3 months
measure: Opioid use and other substance use (drug screen)
timeFrame: 6 months
measure: Mental health functioning
timeFrame: Baseline
measure: Mental health functioning
timeFrame: 3 months
measure: Mental health functioning
timeFrame: 6 months
measure: Mental health functioning
timeFrame: 9 months
measure: Mental health functioning
timeFrame: 12 months
measure: PTSD symptoms
timeFrame: Baseline
measure: PTSD symptoms
timeFrame: 3 months
measure: PTSD symptoms
timeFrame: 6 months
measure: PTSD symptoms
timeFrame: 9 months
measure: PTSD symptoms
timeFrame: 12 months
measure: Mental health impairment
timeFrame: Baseline
measure: Mental health impairment
timeFrame: 3 months
measure: Mental health impairment
timeFrame: 6 months
measure: Mental health impairment
timeFrame: 9 months
measure: Mental health impairment
timeFrame: 12 months
measure: Psychiatric severity
timeFrame: Baseline
measure: Health functioning
timeFrame: Baseline
measure: Health functioning
timeFrame: 3 months
measure: Health functioning
timeFrame: 6 months
measure: Health functioning
timeFrame: 9 months
measure: Health functioning
timeFrame: 12 months
measure: Motivation for treatment
timeFrame: Baseline
measure: Motivation for treatment
timeFrame: 3 months
measure: Motivation for treatment
timeFrame: 6 months
measure: Motivation for treatment
timeFrame: 9 months
measure: Motivation for treatment
timeFrame: 12 months
measure: Suicide Severity
timeFrame: Baseline
measure: Suicide Severity
timeFrame: 3 months
measure: Suicide Severity
timeFrame: 6 months
measure: Suicide Severity
timeFrame: 9 months
measure: Suicide Severity
timeFrame: 12 months
measure: Therapeutic alliance
timeFrame: Baseline
measure: Therapeutic alliance
timeFrame: 3 months
measure: Therapeutic alliance
timeFrame: 6 months
measure: Therapeutic alliance
timeFrame: 9 months
measure: Therapeutic alliance
timeFrame: 12 months
measure: Recovery Capital
timeFrame: Baseline
measure: Recovery Capital
timeFrame: 3 months
measure: Recovery Capital
timeFrame: 6 months
measure: Recovery Capital
timeFrame: 9 months
measure: Recovery Capital
timeFrame: 12 months
measure: Chronic pain
timeFrame: Baseline
measure: Chronic pain
timeFrame: 3 months
measure: Chronic pain
timeFrame: 6 months
measure: Chronic pain
timeFrame: 9 months
measure: Chronic pain
timeFrame: 12 months
measure: Medication Adherence
timeFrame: 3 months
measure: Medication Adherence
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
measure: Quality Adjusted Life Years (QALYs): health
timeFrame: Baseline
measure: Quality Adjusted Life Years (QALYs): health
timeFrame: 3 months
measure: Quality Adjusted Life Years (QALYs): health
timeFrame: 6 months
measure: Quality Adjusted Life Years (QALYs): health
timeFrame: 9 months
measure: Quality Adjusted Life Years (QALYs): health
timeFrame: 12 months
measure: Quality Adjusted Life Years (QALYs): quality of life
timeFrame: Baseline
measure: Quality Adjusted Life Years (QALYs): quality of life
timeFrame: 3 months
measure: Quality Adjusted Life Years (QALYs): quality of life
timeFrame: 6 months
measure: Quality Adjusted Life Years (QALYs): quality of life
timeFrame: 9 months
measure: Quality Adjusted Life Years (QALYs): quality of life
timeFrame: 12 months
Other outcomes:
measure: Economic impact of full MISSION
timeFrame: 6 months
measure: Economic impact of CTI & PS
timeFrame: 6 months
measure: Economic impact of CTI & DRT
timeFrame: 6 months
measure: Economic impact of PS & DRT
timeFrame: 6 months
measure: Economic impact of MOUD alone
timeFrame: 6 months
Locations:
city: Holyoke
country: United States
facility: Behavioral Health Network
state: Massachusetts
city: Orange
country: United States
facility: Behavioral Health Network
state: Massachusetts
city: Springfield
country: United States
facility: Behavioral Health Network
state: Massachusetts
city: Worcester
country: United States
facility: UMass Chan Road to Care Clinic
state: Massachusetts
city: Worcester
country: United States
facility: SaVida Health
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: David Smelson, PsyD
role: PRINCIPAL_INVESTIGATOR
References: