Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05138614
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2021-10-22
Brief Title:
Supporting Treatment Access and Recovery in COD
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-COD
Brief Summary:
This 4-year study will randomize 1000 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 4-year 5-arm randomized control trial with a fractional factorial design among 1000 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 11 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 12 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 21 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 eg recovery capital psychosocial supports and quality of life Hypothesis 22 The effects of MISSION and its parts on health outcomes are moderated by key patient characteristics eg 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 patients needs for greater improvements in health outcomes which will inform a future randomized controlled trial on cost-effective patient-level precision intervention assignment
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 11 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 12 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 21 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 eg recovery capital psychosocial supports and quality of life Hypothesis 22 The effects of MISSION and its parts on health outcomes are moderated by key patient characteristics eg 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 patients needs for greater improvements in health outcomes which will inform a future randomized controlled trial on cost-effective patient-level precision intervention assignment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH128904 | NIH | None | httpsreporternihgovquickSearch1R01MH128904 |