- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05803603
Social Work Assistance and Stipends for Housing (SASH) (SASH)
Social Work Assistance and Stipends for Housing (SASH): Improving Outcomes for Homeless Patients Receiving Methadone for Opioid Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Addiction Treatment Program (ATP)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
Individuals will receive $500 monthly stipend for the first months of the study and will receive twelve months of social work supports to help individuals find permanent housing.
|
Same as arm description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Methadone Doses
Time Frame: 3 months prior to enrollment
|
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
|
3 months prior to enrollment
|
|
Methadone Doses
Time Frame: 3-6 months post enrollment
|
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
|
3-6 months post enrollment
|
|
Methadone Doses
Time Frame: 9-12 months post enrollment.
|
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
|
9-12 months post enrollment.
|
|
Quality of Life Scores
Time Frame: Baseline
|
SF-36 scores 0 (worst) to 100 (best)
|
Baseline
|
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Quality of Life Scores
Time Frame: 6 Month
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SF-36 scores 0 (worst) to 100 (best)
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6 Month
|
|
Quality of Life Scores
Time Frame: 12 Month
|
SF-36 scores 0 (worst) to 100 (best)
|
12 Month
|
|
OUD Checklist Scores
Time Frame: Baseline
|
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.
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Baseline
|
|
OUD Checklist Scores
Time Frame: 6 months
|
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
|
|
OUD Checklist Scores
Time Frame: 12 months
|
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
|
|
Urine Toxicology Tests
Time Frame: Three months prior to enrollment
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 1
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 2
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 3
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 4
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 5
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 6
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 7
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 8
|
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
|
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Urine Toxicology Tests
Time Frame: Month 9
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 10
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 11
|
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
|
|
Urine Toxicology Tests
Time Frame: Month 12
|
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
|
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Housed vs Unhoused at 6 Months
Time Frame: 6 Months
|
Count of participants that are housed at 6 months
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6 Months
|
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Housed vs Unhoused at 6 Months
Time Frame: 12 Months
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Count of housed at 12 month
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12 Months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00100771
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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