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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.
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
AIM 2: Improve QOL
AIM 3: Prevent homelessness
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stipend and Social Work Supports | Behavioral | Same as arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | 3 months prior to enrollment |
| Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | 3-6 months post enrollment |
| Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | 9-12 months post enrollment. |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Addiction Treatment Program (ATP) | Baltimore | Maryland | 21201 | United States |
The study protocol will be made available to other researchers. Because only a small number of participants are being enrolled (N=8) outcomes data will be limited to what can be share without identifying individuals.
The data will be available at the end of the study period for 5 years.
Access criteria to be determined.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Stipend and Social Work Supports: Same as arm description |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Stipend and Social Work Supports: Same as arm description |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | Posted | Mean | Standard Deviation | percent of missed doses | 3 months prior to enrollment |
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Data were collected for 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Stipend and Social Work Supports: Same as arm description |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay Unick | University of Maryland School of Social Work | 410-706-3735 | junick@ssw.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2022 | Mar 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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8 individuals will be recruited and followed for 12 months following the intervention. The intervention includes providing a $500 monthly housing stipend for six months and twelve months of social work support to find permanent housing. Individuals will be asked to provide information thought interviews and clinical records.
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| Three months prior to enrollment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | Baseline |
| Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | 6 Month |
| Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | 12 Month |
| Housed vs Unhoused at 6 Months | Count of participants that are housed at 6 months | 6 Months |
| Housed vs Unhoused at 6 Months | Count of housed at 12 month | 12 Months |
| Participants |
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| Age, Continuous | Mean of Age | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | Posted | Mean | Standard Deviation | Percent Missed | 3-6 months post enrollment |
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| Primary | Methadone Doses | Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome. | Posted | Mean | Standard Deviation | Percent Missed | 9-12 months post enrollment. |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| 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 | Posted | Count of Participants | Participants | Three months prior to enrollment |
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| 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 | Posted | Count of Participants | Participants | Month 1 |
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| 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 | Posted | Count of Participants | Participants | Month 2 |
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| 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 | Posted | Count of Participants | Participants | Month 3 |
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| 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 | Posted | Count of Participants | Participants | Month 4 |
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| 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 | Posted | Count of Participants | Participants | Month 5 |
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| 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 | Posted | Count of Participants | Participants | Month 6 |
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| 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 | Posted | Count of Participants | Participants | Month 7 |
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| 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 | Posted | Count of Participants | Participants | Month 8 |
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| 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 | Posted | Count of Participants | Participants | Month 9 |
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| 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 | Posted | Count of Participants | Participants | Month 10 |
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| 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 | Posted | Count of Participants | Participants | Month 11 |
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| 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 | Posted | Count of Participants | Participants | Month 12 |
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| Primary | Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | Posted | Mean | Standard Deviation | units on a scale | 6 Month |
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| Primary | Quality of Life Scores | SF-36 scores 0 (worst) to 100 (best) | Posted | Mean | Standard Deviation | units on a scale | 12 Month |
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| Primary | Housed vs Unhoused at 6 Months | Count of participants that are housed at 6 months | Posted | Count of Participants | Participants | 6 Months |
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| Primary | Housed vs Unhoused at 6 Months | Count of housed at 12 month | Posted | Count of Participants | Participants | 12 Months |
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| 8 |
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