Social Work Assistance and Stipends for Housing (SASH) (SASH)

April 17, 2025 updated by: George Unick, University of Maryland, Baltimore

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Addiction Treatment Program (ATP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
Quality of Life Scores
Time Frame: 6 Month
SF-36 scores 0 (worst) to 100 (best)
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.
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
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
Housed vs Unhoused at 6 Months
Time Frame: 6 Months
Count of participants that are housed at 6 months
6 Months
Housed vs Unhoused at 6 Months
Time Frame: 12 Months
Count of housed at 12 month
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be available at the end of the study period for 5 years.

IPD Sharing Access Criteria

Access criteria to be determined.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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