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临床试验/NCT03447743
NCT03447743已完成早期 1 期

Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder

Michele Staton1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年9月11日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
9
试验地点
1
主要终点
Study Enrollment

研究概览

简要总结

The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural individuals with opioid use disorder (OUD). The significance of this study is grounded in the public health emergency associated with the opioid epidemic in rural Appalachia, the increased vulnerability of rural individuals with OUD, and the dearth of available and accessible evidence-based treatment in the region. This study has potential to make a significant contribution to the OUD treatment field by advancing knowledge on innovative service delivery models to increase access to evidence-based treatment to reduce the prevalence of opioid use disorders and related health disparities among hard-to-reach, high-risk, underserved populations.

详细描述

The overall aim of this R34 proposal is to examine the feasibility, acceptability, and short-term outcomes associated with an innovative service delivery model to increase adherence to extended-release naltrexone (XR-NTX) during the transition from jail to the community for rural individuals with opioid use disorder (OUD). The significance of this study is grounded in the public health emergency associated with the opioid epidemic in rural Appalachia, the increased vulnerability of rural individuals with OUD, and the dearth of available and accessible evidence-based treatment in the region. This R34 has potential to make a significant contribution to the OUD treatment field by advancing knowledge on innovative service delivery models to increase access to evidence-based treatment to reduce high-risk opioid use and related health disparities among hard-to-reach, high-risk, underserved populations. The study will be accomplished through two specific aims: (1) Adapt XR-NTX services for use in community supervision (P&P) offices to increase adherence during re-entry from jail for rural individuals with OUD. (2) A small scale pilot will be conducted to examine feasibility, acceptability, and short-term outcomes of the adapted protocol on XR-NTX adherence and relapse to opioid use. Rural justice-involved individuals on community supervision with OUD will be invited to initiate XR-NTX and continue injections for up to three months in the community. If this study establishes feasibility of this innovative community-based treatment model for XR-NTX in a rural, underserved area, findings will be used to develop an R01 application to test the approach in a larger RCT during community re-entry from jail among high-risk rural individuals with OUD in Appalachia. The long-term goal of this research is to increase access to evidence-based treatment for OUD among high-risk, underserved populations.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meets criteria for opioid use disorder
  • Anticipated release date within 30 days
  • Opioid free
  • Not currently in methadone or buprenorphine trial
  • No serious medical or psychiatric condition
  • Willingness to enroll in the trial

排除标准

  • Positive study pregnancy test
  • Abnormal liver function tests (5X upper limits of normal)
  • Chronic pain conditions that require opioid therapies
  • Untreated medical or psychiatric disorder
  • Suicidal ideation
  • BMI > 40

研究组 & 干预措施

XR-NTX services as usual

Other

Participants will receive on-going XR-NTX injections in a local community clinic

干预措施: XR-NTX community location (Drug)

结局指标

主要结局

Study Enrollment

时间窗: 3 months

Study enrollment is defined as the number of participants who initiate XR-NTX.

次要结局

  • Number of Participants With Opioid Relapse(3 months)

研究者

发起方
Michele Staton
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michele Staton

Associate Professor

University of Kentucky

研究点 (1)

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