Supporting Treatment Access and Recovery in COD

Opioid Use Disorder Clinical Trial

— STAR-COD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138614
• Other study ID #: H00023911
• Secondary ID: 1R01MH128904
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2023
• Source: University of Massachusetts, Worcester
• Contact: David Smelson, PsyD
• Phone: 508-713-5420
• Email: David.Smelson[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a 4-year, 5-arm randomized control trial with a fractional factorial design among 1,000 patients across MOUD programs in 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• Medication for Opioid Use Disorder
medication management

Behavioral:
• MISSION Critical Time Intervention
offering intensive community-based services that decrease in intensity over time
• MISSION Peer Support
including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders
• MISSION Dual Recovery Therapy
comprised of 13 structured co-occurring disorders treatment sessions

Locations

Country	Name	City	State
United States	Behavioral Health Network	Holyoke	Massachusetts
United States	Behavioral Health Network	Orange	Massachusetts
United States	Behavioral Health Network	Springfield	Massachusetts
United States	SaVida Health	Worcester	Massachusetts
United States	UMass Chan Road to Care Clinic	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Harvard Medical School (HMS and HSDM), National Institute of Mental Health (NIMH), University of Massachusetts, Lowell, University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic impact of full MISSION	Cost of full MISSION and MOUD measured by Patient-Reported Outcomes Measurement Information System-Preference (PROPr)	6 months
Other	Economic impact of CTI & PS	Cost of MISSION CTI, PS, and MOUD measured by PROPr	6 months
Other	Economic impact of CTI & DRT	Cost of MISSION CTI, DRT, and MOUD measured by PROPr	6 months
Other	Economic impact of PS & DRT	Cost of MISSION PS, DRT, and MOUD measured by PROPr	6 months
Other	Economic impact of MOUD alone	Cost of MOUD alone measured by PROPr	6 months
Primary	Engagement in treatment	Measured by total days in treatment	6 months
Primary	Engagement in medication for opioid use disorder (MOUD)	Measured by percentage of days receiving MOUD	6 months
Primary	Engagement in outreach and linkage sessions	Measured by total number of outreach and linkage sessions	6 months
Primary	Self-report opioid use and other substance use	Measured by self-report days of use	Baseline
Primary	Self-report opioid use and other substance use	Measured by self-report days of use	3 months
Primary	Self-report opioid use and other substance use	Measured by self-report days of use	6 months
Primary	Self-report opioid use and other substance use	Measured by self-report days of use	9 months
Primary	Self-report opioid use and other substance use	Measured by self-report days of use	12 months
Primary	Opioid use and other substance use (drug screen)	Measured by positive drug screens	3 months
Primary	Opioid use and other substance use (drug screen)	Measured by positive drug screens	6 months
Primary	Mental health functioning	Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)	Baseline
Primary	Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	3 months
Primary	Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	6 months
Primary	Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	9 months
Primary	Mental health functioning	Measured by self-report mental health symptoms on BASIS-24	12 months
Primary	PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	Baseline
Primary	PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	3 months
Primary	PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	6 months
Primary	PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	9 months
Primary	PTSD symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	12 months
Primary	Mental health impairment	Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)	Baseline
Primary	Mental health impairment	Measured by self-report on WHODAS 2.0	3 months
Primary	Mental health impairment	Measured by self-report on WHODAS 2.0	6 months
Primary	Mental health impairment	Measured by self-report on WHODAS 2.0	9 months
Primary	Mental health impairment	Measured by self-report on WHODAS 2.0	12 months
Primary	Psychiatric severity	Measured by Structured Clinical Interview for DSM-5 (SCID-RV)	Baseline
Primary	Health functioning	Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)	Baseline
Primary	Health functioning	Measured by the WHOQOL-BREF	3 months
Primary	Health functioning	Measured by the WHOQOL-BREF	6 months
Primary	Health functioning	Measured by the WHOQOL-BREF	9 months
Primary	Health functioning	Measured by the WHOQOL-BREF	12 months
Primary	Motivation for treatment	Measured by Stages of Change, Readiness, and Treatment Eagerness Scale (SOCRATES)	Baseline
Primary	Motivation for treatment	Measured by SOCRATES	3 months
Primary	Motivation for treatment	Measured by SOCRATES	6 months
Primary	Motivation for treatment	Measured by SOCRATES	9 months
Primary	Motivation for treatment	Measured by SOCRATES	12 months
Primary	Suicide Severity	Measured by Columbia- Suicide Severity Rating Scale (C-SSRS)	Baseline
Primary	Suicide Severity	Measured by C-SSRS	3 months
Primary	Suicide Severity	Measured by C-SSRS	6 months
Primary	Suicide Severity	Measured by C-SSRS	9 months
Primary	Suicide Severity	Measured by C-SSRS	12 months
Primary	Therapeutic alliance	Measured by Working Alliance Inventory	Baseline
Primary	Therapeutic alliance	Measured by Working Alliance Inventory	3 months
Primary	Therapeutic alliance	Measured by Working Alliance Inventory	6 months
Primary	Therapeutic alliance	Measured by Working Alliance Inventory	9 months
Primary	Therapeutic alliance	Measured by Working Alliance Inventory	12 months
Primary	Recovery Capital	Measured by Assessment of Recovery Capital	Baseline
Primary	Recovery Capital	Measured by Assessment of Recovery Capital	3 months
Primary	Recovery Capital	Measured by Assessment of Recovery Capital	6 months
Primary	Recovery Capital	Measured by Assessment of Recovery Capital	9 months
Primary	Recovery Capital	Measured by Assessment of Recovery Capital	12 months
Primary	Chronic pain	Measured by Chronic Pain assessment	Baseline
Primary	Chronic pain	Measured by Chronic Pain assessment	3 months
Primary	Chronic pain	Measured by Chronic Pain assessment	6 months
Primary	Chronic pain	Measured by Chronic Pain assessment	9 months
Primary	Chronic pain	Measured by Chronic Pain assessment	12 months
Primary	Overall well-being	Measured by EQ-5D-5L	1 month
Primary	Overall well-being	Measured by EQ-5D-5L	2 months
Primary	Overall well-being	Measured by EQ-5D-5L	3 months
Primary	Overall well-being	Measured by EQ-5D-5L	4 months
Primary	Overall well-being	Measured by EQ-5D-5L	5 months
Primary	Overall well-being	Measured by EQ-5D-5L	6 months
Primary	Medication Adherence	Measured by Medication Adherence Rating Scale	1 month
Primary	Medication Adherence	Measured by Medication Adherence Rating Scale	2 months
Primary	Medication Adherence	Measured by Medication Adherence Rating Scale	3 months
Primary	Medication Adherence	Measured by Medication Adherence Rating Scale	4 months
Primary	Medication Adherence	Measured by Medication Adherence Rating Scale	5 months
Primary	Medication Adherence	Measured by Medication Adherence Rating Scale	6 months
Secondary	Mortality	Data extracted from medical records	6 months