Social Work Assistance and Stipends for Housing (SASH)

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05803603
Collaborator
(none)
8
1
1
13
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Stipend and Social Work Supports
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Social Work Assistance and Stipends for Housing (SASH): Improving Outcomes for Homeless Patients Receiving Methadone for Opioid Use Disorder
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Behavioral: Stipend and Social Work Supports
Same as arm description

Outcome Measures

Primary Outcome Measures

  1. Methadone Doses [3 months prior to enrollment]

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

  2. Methadone Doses [3-6 months post enrollment]

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

  3. Methadone Doses [9-12 months post enrollment.]

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

  4. OUD Checklist scores [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline]

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

  21. Quality of Life Scores [6 Month]

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

  22. Quality of Life Scores [12 Month]

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

  23. Number of Days Homeless [6 Months]

    Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)

  24. Number of Days Homeless [12 Months]

    Percentage of Days of Experiencing Homelessness. 0 (best) to 100 (worse)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Addiction Treatment Program (ATP) Baltimore Maryland United States 21201

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
George Unick, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT05803603
Other Study ID Numbers:
  • HP-00100771
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023