NCT05803603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

March 23, 2023

Results QC Date

March 18, 2025

Last Update Submit

April 17, 2025

Conditions

Outcome Measures

Primary Outcomes (24)

  • Methadone Doses

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

    3 months prior to enrollment

  • Methadone Doses

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

    3-6 months post enrollment

  • Methadone Doses

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

    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.

    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.

    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.

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Month 12

  • Quality of Life Scores

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

    Baseline

  • Quality of Life Scores

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

    6 Month

  • Quality of Life Scores

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

    12 Month

  • Housed vs Unhoused at 6 Months

    Count of participants that are housed at 6 months

    6 Months

  • Housed vs Unhoused at 6 Months

    Count of housed at 12 month

    12 Months

Study Arms (1)

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.

Behavioral: Stipend and Social Work Supports

Interventions

Same as arm description

Intervention Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Addiction Treatment Program (ATP)

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Jay Unick
Organization
University of Maryland School of Social Work

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 7, 2023

Study Start

December 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

April 18, 2025

Results First Posted

April 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available at the end of the study period for 5 years.
Access Criteria
Access criteria to be determined.

Locations