Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Changes in fMRI activity level during natural reward processing
研究概览
简要总结
The overarching aim of this project is to conduct a randomized controlled study to determine whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 21-60 years of age
- •English fluency
- •20/20 vision with corrective lenses
- •current chronic, non-neuropathic back pain diagnosis determined by physician assessment
- •reporting pain ≥3 on 0-10 scale with opioid medication
- •current use of prescription opioids for ≥3 consecutive months
- •ability to understand study procedures and to comply with them for the entire length of the study
排除标准
- •Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation)
- •untreated, active suicidality in the past month
- •and severe non-opioid substance use disorder in the past year as assessed with the MINI
- •clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain
- •inability or unwillingness of individual to give written informed consent
- •physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
结局指标
主要结局
Changes in fMRI activity level during natural reward processing
时间窗: Change from week 0 to 8 weeks
Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan.
Changes in endogenous opioid system function in response to pain challenge
时间窗: Change from week 0 to 8 weeks
PET opioid receptor binding potential from baseline through pain challenge
次要结局
- Pain sensitivity as a measure of volume of hypertonic saline(Change from week 0 to 8 weeks)
- Self-report affect ratings(Change from week 0 to 8 weeks)
- Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use(Change from week 0 to 8 weeks)
研究者
Eric Garland
Associate Director of Integrative Medicine in Supportive Oncology and Survivorship, Huntsman Cancer Institute; Associate Dean for Research and Associate Professor, College of Social Work
University of Utah