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临床试验/NCT05588726
NCT05588726撤回不适用

Behavioral Intervention to Improve Insomnia Symptoms in Patients With Opioid Use Disorder

University of Pennsylvania2 个研究点 分布在 1 个国家开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Sleep Onset Latency

研究概览

简要总结

This randomized, 35-day research study (n=20) explores the effects of a simplified mindfulness intervention in opioid use disorder patients stabilized on buprenorphine maintenance therapy (BMT), aiming to alleviate insomnia, monitor BMT dose, and decrease non-prescribed opioid use. Patients tap along with their breathing at bedtime and practice sleep hygiene; controls do sleep hygiene only. Adherence will be monitored by a smartphone application.

详细描述

This research study is exploring the effects of a simplified mindfulness intervention in patients with opioid use disorder who are stabilized on buprenorphine maintenance therapy. This study aims to improve their sleep quality, monitor changes in buprenorphine dose, and decrease the frequency of non-prescribed opioids use. We will be enrolling a total of 20 patients who are above 18 years of age and have insomnia symptoms, opioid use disorder, and access to a smartphone. Patients will be asked to utilize a smartphone application which will allow us to monitor adherence; they will be asked to tap on the screen in time with their breathing before bedtime. Buprenorphine maintenance therapy is used to treat opioid use disorder (the buprenorphine will be prescribed by their healthcare provider as part of their standard clinical care and is not a research study intervention) by minimizing withdrawal symptoms, but symptoms of insomnia often persist. Symptoms of insomnia include difficulty falling/staying asleep, anxiety regarding sleep, or daytime sleepiness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Age greater than 18
  • Diagnosed with Opioid Use Disorder
  • Stable on Buprenorphine Maintenance Therapy for at least 4 weeks
  • At least 3 nights of greater than 30 minutes of sleep onset latency
  • Speak English above 6th grade level
  • Access to smart device

排除标准

  • Inability to communicate verbally
  • Involved in another insomnia study
  • Medical or other factors that in the opinion of the study research team would interfere with their ability to participate in the intervention

结局指标

主要结局

Sleep Onset Latency

时间窗: Day 28

Time to fall asleep as derived from the Sleep Diary

次要结局

  • Daytime Cravings(Days 1 through 14)
  • Non-Prescribed Opioid Use(Days -1, 7, 14, and 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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