跳至主要内容
临床试验/NCT06288256
NCT06288256招募中不适用

Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Current Opioid Misuse Measure (COMM) Score

研究概览

简要总结

Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.

To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.

This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age over 18
  • With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation

排除标准

  • Severe psychiatric condition interfering with study participation Any major cardiac, pulmonary, renal, infectious, hepatic condition that interferes with study participation
  • Polytrauma
  • Prolonged hospitalization (>10days)
  • Pregnancy
  • Known surgery cancellation within study period

结局指标

主要结局

Current Opioid Misuse Measure (COMM) Score

时间窗: Up to 12 months post-operatively

The Current Opioid Misuse Measure (COMM) is a 17-item self-report measure with total scores ranging from 0 to 68 that is used to identify risk of opioid misuse among chronic pain patients, with higher scores indicating higher risk of opioid misuse.

次要结局

  • Numerical Rating Scale (NRS) Score(Up to 12 months post-operatively)

研究者

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

Chinwe Nwaneshiudu

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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