Social Work Assistance and Stipends for Housing (SASH)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05803603

Acronym

SASH

Enrollment

Registered

2023-04-07

Start date

2022-12-01

Completion date

2024-01-01

Last updated

2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Housing Problems, Opioid-Related Disorders

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.

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

Interventions

BEHAVIORALStipend and Social Work Supports

Same as arm description

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Methadone Doses	3 months prior to enrollment	Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
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.
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
Quality of Life Scores	Baseline	SF-36 scores 0 (worst) to 100 (best)
Housed vs Unhoused at 6 Months	6 Months	Count of participants that are housed at 6 months

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	8
Total	8

Baseline characteristics

Characteristic	Intervention Arm
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	8 Participants
Age, Continuous	46.75 years STANDARD_DEVIATION 8.75
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	4 Participants
Region of Enrollment United States	8 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 8
other Total, other adverse events	0 / 8
serious Total, serious adverse events	0 / 8

Outcome results

Primary

Housed vs Unhoused at 6 Months

Count of housed at 12 month

Time frame: 12 Months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Intervention Arm	Housed vs Unhoused at 6 Months	3 Participants

Comparison: We recruited 8 homeless individuals and followed them for 12 months. 4 individuals (50%) were housed at 6 months and 3 (37.5) were housed at 12 months.p-value: 0.12595% CI: [0.37, 10.92]McNemar

Primary

Housed vs Unhoused at 6 Months

Count of participants that are housed at 6 months

Time frame: 6 Months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Intervention Arm	Housed vs Unhoused at 6 Months	4 Participants

Primary

Methadone Doses

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

Time frame: 3-6 months post enrollment

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Methadone Doses	7.47 Percent Missed	Standard Deviation 7.94

Primary

Methadone Doses

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

Time frame: 9-12 months post enrollment.

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Methadone Doses	34.11 Percent Missed	Standard Deviation 32.11

Primary

Methadone Doses

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

Time frame: 3 months prior to enrollment

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Methadone Doses	4.58 percent of missed doses	Standard Deviation 4.58

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.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	OUD Checklist Scores	8.25 units on a scale	Standard Deviation 7.4

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.

Time frame: 12 months

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	OUD Checklist Scores	7.2 units on a scale	Standard Deviation 5.3

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.

Time frame: 6 months

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	OUD Checklist Scores	7.4 units on a scale	Standard Deviation 4.4

Primary

Quality of Life Scores

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

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Quality of Life Scores	34.4 units on a scale	Standard Deviation 14.5

Primary

Quality of Life Scores

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

Time frame: 6 Month

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Quality of Life Scores	31 units on a scale	Standard Deviation 10.8

Primary

Quality of Life Scores

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

Time frame: 12 Month

Arm	Measure	Value (MEAN)	Dispersion
Intervention Arm	Quality of Life Scores	32 units on a scale	Standard Deviation 10.4

Primary