Imaging, Cognition, and Opioids in Older Adults With Chronic Pain (I-COAP) Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- White matter fractional anisotropy (FA) of corpus callosum
研究概览
简要总结
The purpose of this study is to determine whether exposure to prescription opioids is associated with brain structural changes on magnetic resonance imaging (MRI), with the primary outcome of white matter integrity as measured by fractional anisotropy of the corpus callosum.
详细描述
The investigators will recruit 200 adults aged 65 years and older with chronic pain of the knee or shoulder. Each will receive an individualized multimodal pain treatment pathway for 6-weeks - for half of participants this will include a prescription opioid; the other half will receive an identical placebo. After 6 weeks, participants will undergo opioid/placebo taper. The investigators will obtain neuroimaging (MRI), psychometric/cognitive testing, pain scores, and several exploratory patient-reported outcomes at several time-points: before the intervention (all tests), at 6 weeks (all tests except MRI), 6-month phone call (only phone based patient reported outcomes- no MRI), and at 1 year (all tests).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All parties are masked other than the individual that will be dispensing the drug and preparing the medication (Placebo vs. Opioid).
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or older
- •Pain for longer than 3 months (chronic)
- •Moderate to severe pain nearly every day (averaged PEG score >5)
- •Persistent pain despite use of >1 analgesic (Tylenol, Ibuprofen, lidocaine patch, etc)
排除标准
- •Untreated severe/uncontrolled Mental health (schizophrenia, bipolar disorder, psychosis, history of suicidality, depression or anxiety, PTSD)
- •Severe liver (cirrhosis) or kidney disease (ESRD on dialysis or GFR< 30)
- •Cognitive impairment (Kokmen Short Test of Mental Status score < 29)
- •Life expectancy < 12 months
- •Contraindications to MRI
- •Non-English speaking
- •Opioid use within the past 6 months
- •Contraindications or previous intolerance to prescription opioids
- •Substance use disorder or high-risk for opioid-related adverse effects (Opioid Risk Tool ≥ 8)
- •Residence outside of Minnesota or Wisconsin during opioid intervention period
- •Another pain generator that is greater than their knee or shoulder or low back pain
- •Anticipated surgery for joint replacement (Knee or shoulder) sooner than 3 months.
研究组 & 干预措施
Opioid Group
The participant will be plugged into an individualized comprehensive tiered pain plan that can include: Tier one (Acetaminophen, NSAIDS, Topicals, TENS unit, Massage, Acupuncture, Physical therapy. Tier two (Cognitive behavioral therapy, joint injections, nerve ablations, peripheral nerve stimulators) and less commonly Tier three (duloxetine, gabapentin). This is modeled after clinical practice. The participants will additionally receive prescription opioids for 6 weeks.
干预措施: Opioid (Drug)
Placebo Group
The participant will be plugged into an individualized comprehensive tiered pain plan that can include: Tier one (Acetaminophen, NSAIDS, Topicals, TENS unit, Massage, Acupuncture, Physical therapy. Tier two (Cognitive behavioral therapy, joint injections, nerve ablations, peripheral nerve stimulators) and less commonly Tier three (duloxetine, gabapentin). This is modeled after clinical practice. The participants will additionally receive a prescription opioid placebo for 6 weeks.
干预措施: Opioid Placebo (Drug)
结局指标
主要结局
White matter fractional anisotropy (FA) of corpus callosum
时间窗: Baseline, 12 months
Fractional anisotropy of the corpus callosum, adjusted against baseline value.
次要结局
- Gray matter cortical thickness(Baseline, 12 months)
- Digit span memory test(Baseline, 6 weeks, 12 months)
- White matter fractional anisotropy (FA) of other axonal tracts(Baseline, 12 months)
- Subcortical gray matter volumes(Baseline, 12 months)
- Mayo Preclinical Alzheimer's disease Cognitive Composite (Mayo-PACC) Global-z(Baseline, 6 weeks, 12 months)
- Trailmaking Test A(Baseline, 6 weeks, 12 months)
- Mayo Test Drive(Baseline, 6 weeks, 6 month web based, 1 year)
研究者
Nafisseh S. Warner
Principal Investigator
Mayo Clinic