Social Work Assistance and Stipends for Housing (SASH)

Opioid-Related Disorders Clinical Trial

— SASH  

Official title:

Social Work Assistance and Stipends for Housing (SASH): Improving Outcomes for Homeless Patients Receiving Methadone for Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803603
• Other study ID #: HP-00100771
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SASH is a clinical trial feasibility study that will provide an intervention to improve Opioid Use Disorder (OUD), Quality of Life (QOL), and housing outcomes for homeless patients receiving Medication for Opiate Use Disorder (MOUD). The main questions of the study are does a $500 housing stipend for individuals on MOUD increase treatment retention, improved quality of life and prevent homelessness.

Description:

SASH is a clinical trial feasibility study that will provide an housing stipend for 8 individuals (N=8) experience homelessness and currently being treated for OUD to improve OUD treatment outcomes, QOL, and housing outcomes. To achieve these goals, patients will receive monthly $500 housing stipends that can be used for a broad range of temporary housing included in a list of resources compiled by the study. These stipends will be accompanied by Social Work assistance to find permanent housing which will last the full 12 months of the study. SASH will recruit OUD patients receiving MOUD who are struggling with homelessness, defined as living in an emergency shelter or a place not meant for habitation instead of a fixed, regular, and adequate nighttime residence. This definition is consistent with the one used by the U.S. Department of Housing and Urban Development. The patients will be recruited from the University of Maryland Addiction Treatment Program (ATP), a certified Substance Use Disorder (SUD) treatment program that provides MOUD and collocates medical care, wellness programs, and research. Patients will be eligible for SASH if they experienced homelessness during at least 15 of the 30 days preceding the dispensing of the first month's stipends.SASH will accomplish its goals using the following aims and objectives: AIM 1: Improve OUD outcomes - Hypothesis 1a: Patients will miss fewer methadone doses and receive more take-home methadone doses after receiving the stipends and Social Work assistance Endpoint: Percentages of missed and take-home methadone doses, as recorded by the software tracking methadone-dispensing at the ATP, in the 3-month period before the study, between Month 3 and 6 of the study, and between Month 9 and 12 of the study - Hypothesis 1b: Patients will experience an improvement in their OUD after receiving the stipends and Social Work assistance Endpoint: OUD Checklist scores completed at Day 0, Month 6, and Month 12 of the study - Hypothesis 1c: Patients will use fewer opioids and illicit substances after receiving the stipends and Social Work assistance Endpoint: Monthly urine toxicology tests (UTT) three months before study entry and monthly during the study AIM 2: Improve QOL - Hypothesis 2a: Patients will experience improvement in QOL during the study Endpoint: SF-36 scores at Day 0, Month 6, and Month 12 of the study - Hypothesis 2b: Patients will report benefit from receiving the stipends and Social Work assistance AIM 3: Prevent homelessness - Hypothesis 3a: The monthly $500 stipends will prevent patients from being homeless Endpoint: Percentage of days patients are homeless during the 6-month period stipends are distributed - Hypothesis 3b: Patients will be in housing by the end of the study Endpoint: Percentage of patients who are homeless or in either permanent or temporary housing by Month 12 of the study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Experienced homelessness during at least 15 of the 30 days preceding enrollment
• Is a patient at the University of Maryland Addiction Treatment Program (ATP) receiving methadone treatment. Exclusion Criteria: -

Related Conditions & MeSH terms

• Housing Problems
• Opioid-Related Disorders

Intervention

Behavioral:
• Stipend and Social Work Supports
Same as arm description

Locations

Country	Name	City	State
United States	University of Maryland Addiction Treatment Program (ATP)	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methadone Doses	Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.	3 months prior to enrollment
Primary	Methadone Doses	Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.	3-6 months post enrollment
Primary	Methadone Doses	Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.	9-12 months post enrollment.
Primary	OUD Checklist scores	Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.	Baseline
Primary	OUD Checklist scores	Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.	6 months
Primary	OUD Checklist scores	Scores on the Diagnostic and Statistical Manual V OUD checklist. Range 0 - 13. Higher scores mean worse outcome with 2-3 as mild severity, 4-5 moderate severity and 6 or more as severe.	12 months
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Three months prior to enrollment
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 1
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 2
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 3
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 4
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 5
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 6
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 7
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 8
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 9
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 10
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 11
Primary	Urine toxicology tests	Detection of positive urine toxicology tests collected from chart reviews. Values are positive or negative for controlled substances. Positive test the worse outcome	Month 12
Primary	Quality of Life Scores	SF-36 scores 0 (worst) to 100 (best)	Baseline
Primary	Quality of Life Scores	SF-36 scores 0 (worst) to 100 (best)	6 Month
Primary	Quality of Life Scores	SF-36 scores 0 (worst) to 100 (best)	12 Month
Primary	Number of Days Homeless	Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)	6 Months
Primary	Number of Days Homeless	Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)	12 Months