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临床试验/NCT05803603
NCT05803603已完成不适用

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

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Methadone Doses

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Stipend and Social Work Supports (Behavioral)

结局指标

主要结局

Methadone Doses

时间窗: 9-12 months post enrollment.

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

OUD Checklist Scores

时间窗: 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

时间窗: 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

时间窗: 12 Month

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

Housed vs Unhoused at 6 Months

时间窗: 12 Months

Count of housed at 12 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Unick

Professor

University of Maryland, Baltimore

研究点 (2)

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