Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
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
- 否
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
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
Nina A. Cooperman, Psy. D.
Associate Professor
Rutgers, The State University of New Jersey
