跳至主要内容
临床试验/NCT06032559
NCT06032559招募中3 期

Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain

Rutgers, The State University of New Jersey4 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2023年9月4日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
450
试验地点
4
主要终点
Days of drug use

研究概览

简要总结

This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:

  • Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement.
  • Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.

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
Double (Investigator, Outcomes Assessor)

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

  • English-speaking
  • currently on methadone
  • persistent or recurring pain that has lasted for a duration of 3 months of longer.

排除标准

  • severe cognitive impairment (score >23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
  • suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
  • inability to attend or fully participate in intervention sessions or assessments
  • previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).

研究组 & 干预措施

Treatment-as-Usual

Active Comparator

Methadone treatment as usual.

干预措施: TAU (Other)

结局指标

主要结局

Days of drug use

时间窗: Baseline through 52 weeks

mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.

次要结局

  • Chronic Pain(Baseline through 52 weeks)

研究者

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

Nina A. Cooperman, Psy. D.

Associate Professor

Rutgers, The State University of New Jersey

研究点 (4)

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