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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05803603
Other study ID # HP-00100771
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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