Neurobiological Consequences of Long-Term Opioid Therapy in the Brain and Spinal Cord
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy
研究概览
简要总结
The purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy.
详细描述
The objective of the study is to determine differences in neurophysiology and behavior during different phases of opioid use in patients. Study activities will include neuroimaging (MRI and fMRI), behavioral tasks, sensory testing, blood draws, and questionnaires. The neuroimaging data will be analyzed using specialized software; data from questionnaires, sensory testing, and behavioral task performance will be analyzed using standard statistical software. Risks and safety concerns include standard, minimal risks associated with MRI scans, sensory testing, blood draws, and confidentiality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for Healthy Controls:
- •female and ages 18+
- •ability to read/understand English and give consent to participate
- •no current or history of chronic pain
- •not regularly taking any pain-relieving or mood-altering medications (per PI discretion)
- •absence of use of opioid medications
- •Inclusion Criteria for Individuals with Chronic Pain:
- •female and ages 18 +
- •ability to read/understand English and give consent to participate
- •self-reported or physician diagnosis of fibromyalgia and/or chronic pain
- •current use of opioid medication(s) for inclusion in the opioid patient group -OR- absence of use of opioid medications for inclusion in the non-opioid patient group
排除标准
- •(for both groups):
- •limited ability to participate fully in behavioral tasks, longitudinal follow-up
- •MRI contraindication
- •any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study
研究组 & 干预措施
Healthy controls
Healthy female participants who are not taking opioids will undergo one study visit
Female adults with chronic pain who take prescribed opioid medications
Opioid taking participants will undergo two study visits, one for each opioid phase ("peak" or "trough")
干预措施: Opioid Phase (Other)
Female adults with chronic pain who do not take opioid medications
Participants with chronic pain who are not taking opioids will undergo one study visit
结局指标
主要结局
Characterize brain fMRI-based activity related to neurobiological consequences of opioid therapy
时间窗: During study visits up to 4 weeks apart
Compare brain fMRI-based response to reward stimuli during a monetary incentive delay (MID) task and functional connectivity of brain reward circuitry during resting state.
次要结局
- Characterize spinal cord fMRI-based activity related to neurobiological consequences of opioid therapy(During study visits up to 4 weeks apart)