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临床试验/NCT05034276
NCT05034276已完成不适用

Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder

University of Utah2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Number of Participants With Adverse Events and/or Serious Adverse Events

研究概览

简要总结

This is a Phase 1 trial that aims to establish the safety of MORE-VR, as well as to collect feasibility, usability, and engagement data, for patients receiving medications for opioid use disorder (mOUD).

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • DSM-5 opioid use disorder diagnosis
  • treated with medications for opioid use disorder (MOUD)

排除标准

  • Mindfulness intervention experience (MBSR, MBRP)
  • Active psychosis or high risk of suicidality
  • Cognitive impairment (per self-report or report by clinician)
  • Unwilling or unable to remain in MOUD treatment for duration of study

结局指标

主要结局

Number of Participants With Adverse Events and/or Serious Adverse Events

时间窗: Baseline through week 8

Number of participants who reported adverse events and serious adverse events.

次要结局

  • Numeric Rating Scale of State Craving(Baseline through week 8)
  • Engagement(Baseline through week 8)
  • Numeric Rating Scale of State Positive Affect(Baseline through week 8)

研究者

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

Eric Garland

Distinguished Professor

University of Utah

研究点 (2)

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