COMT Activity as a Biomarker for Hypnotizability and Hypnotic Analgesia Using a Multiplexed Precision Medicine Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Percent concordance of rapid genotyping of SNPs with giant magnetoresistive sensors vs. genotyping using pyrosequencing
研究概览
简要总结
Hypnosis is an effective pain management tool for surgery that can reduce opioid use up to 40%. COMT single nucleotide polymorphisms (SNPs) can predict pain sensitivity and opioid use perioperatively, and may also be associated with hypnotizability or response to hypnotic analgesia. Analyzing COMT haplotypes from DNA extracted from saliva or blood using a giant magnetoresistive (GMR) nanotechnology platform may be faster, less expensive, and at least as accurate as pyrosequencing. This study aims to validate a multi-SNP point-of-care (POC) GMR assay for the rapid genotyping of SNPs predictive of COMT activity, and test the feasibility of using COMT activity as a biomarker for hypnotizability and/or response to hypnotic analgesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Prior enrollment in one of 3 specific hypnosis trials
- •Enrollment is by invitation only
排除标准
- •Participants in the prior trials who declined to be contacted for future research.
研究组 & 干预措施
Participants with HIP previously measured
This cohort of patients will have their genetics analyzed and compared to their HIP scores.
干预措施: Giant magnetoresistive sensor (GMR) (Device)
Participants without HIP measured
This cohort of patients from the control group of the knee replacement trial (who did not have their HIP measured) will have their genetics, pain, and opioid use analyzed, and compared to the genetics, pain, and opioid use of the hypnosis group from that trial.
干预措施: Giant magnetoresistive sensor (GMR) (Device)
结局指标
主要结局
Percent concordance of rapid genotyping of SNPs with giant magnetoresistive sensors vs. genotyping using pyrosequencing
时间窗: Through study completion, average of 2 years
We will test the hypothesis that the four COMT SNPs (rs4680, rs4818, rs4633, and rs6269) can be detected on the GMR platform with 99% accuracy when compared to pyrosequencing
Determine which COMT SNP haplotypes associate with high/medium/low hypnotizability measured by the Hypnotic Induction Profile score.
时间窗: Through study completion, average of 2 years
次要结局
- Determine which COMT diplotypes/haplotypes associate with high/medium/low postoperative opioid use in milligram morphine equivalents/hour/kilogram of body weight (MME/kg/hr), and high/medium/low average pain scores on the Numeric Pain Scale.(Through study completion, average of 2 years)
研究者
Jessie Markovits
Assistant Professor of Medicine
Stanford University