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Completed

NCT Number: NCT05803603

Social Work Assistance and Stipends for Housing (SASH)

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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Housing Problems Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Addiction Treatment Program (ATP)

Baltimore, Maryland, 21201, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Stipend and Social Work Supports

Behavioral

Same as arm description

Primary outcomes

  1. Methadone Doses

    Time frame: 3 months prior to enrollment

    Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.

  2. Methadone Doses

    Time frame: 3-6 months post enrollment

    Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.

  3. Methadone Doses

    Time frame: 9-12 months post enrollment.

    Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.

  4. 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.

  5. 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. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. Quality of Life Scores

    Time frame: Baseline

    SF-36 scores 0 (worst) to 100 (best)

  21. Quality of Life Scores

    Time frame: 6 Month

    SF-36 scores 0 (worst) to 100 (best)

  22. Quality of Life Scores

    Time frame: 12 Month

    SF-36 scores 0 (worst) to 100 (best)

  23. Housed vs Unhoused at 6 Months

    Time frame: 6 Months

    Count of participants that are housed at 6 months

  24. Housed vs Unhoused at 6 Months

    Time frame: 12 Months

    Count of housed at 12 month

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Acronym: SASH

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2023
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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