Opioid-Related DisordersSASHNCT05803603
Social Work Assistance and Stipends for Housing (SASH)
A study testing Stipend and Social Work Supports in people with Opioid-Related Disorders and Housing Problems, run by University of Maryland, Baltimore at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid-Related Disorders, Housing Problems
- What is being tested?
- Stipend and Social Work Supports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Addiction Treatment Program (ATP)
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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
- Conditions
- Opioid-Related Disorders, Housing Problems
- Being tested
- Stipend and Social Work Supports
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stipend and Social Work SupportsBehavioural
Same as arm description
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Stipend and Social Work Supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methadone Doses
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Measured: 3 months prior to enrollment
Methadone Doses
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Measured: 3-6 months post enrollment
Methadone Doses
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Measured: 9-12 months post enrollment.
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.
Measured: Baseline
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.
Measured: 6 months
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.
Measured: 12 months
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
Measured: Three months prior to enrollment
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
Measured: Month 1
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
Measured: Month 2
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
Measured: Month 3
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
Measured: Month 4
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
Measured: Month 5
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
Measured: Month 6
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
Measured: Month 7
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
Measured: Month 8
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
Measured: Month 9
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
Measured: Month 10
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
Measured: Month 11
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
Measured: Month 12
Quality of Life Scores
SF-36 scores 0 (worst) to 100 (best)
Measured: Baseline
Quality of Life Scores
SF-36 scores 0 (worst) to 100 (best)
Measured: 6 Month
Quality of Life Scores
SF-36 scores 0 (worst) to 100 (best)
Measured: 12 Month
Housed vs Unhoused at 6 Months
Count of participants that are housed at 6 months
Measured: 6 Months
Housed vs Unhoused at 6 Months
Count of housed at 12 month
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Dec 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Unick, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803603
- Sponsor's protocol ID
- HP-00100771
- Acronym
- SASH
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2023
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Work Assistance and Stipends for Housing (SASH): Improving Outcomes for Homeless Patients Receiving Methadone for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05803603
- Acronym / sponsor ID
- SASH / HP-00100771
- Conditions
- Opioid-Related Disorders, Housing Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Stipend and Social Work SupportsIndividuals 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stipend and Social Work SupportsSame as arm description | Behavioural | Intervention Arm |
Primary outcome
Methadone Doses
Time frame: 3 months prior to enrollment
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Methadone Doses
Time frame: 3-6 months post enrollment
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
Methadone Doses
Time frame: 9-12 months post enrollment.
Percentage of Missed Methadone Doses, Range 0 - 100%, Lower percentages mean better outcome.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
Quality of Life Scores
Time frame: Baseline
SF-36 scores 0 (worst) to 100 (best)
Quality of Life Scores
Time frame: 6 Month
SF-36 scores 0 (worst) to 100 (best)
Quality of Life Scores
Time frame: 12 Month
SF-36 scores 0 (worst) to 100 (best)
Housed vs Unhoused at 6 Months
Time frame: 6 Months
Count of participants that are housed at 6 months
Housed vs Unhoused at 6 Months
Time frame: 12 Months
Count of housed at 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stipend and Social Work Supports in people with Opioid-Related Disorders and Housing Problems, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methadone Doses (time frame: 3 months prior to enrollment). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.