COMT Activity and Hypnotizability

Study Overview
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Brief Summary
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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.

Official Title
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COMT Activity as a Biomarker for Hypnotizability and Hypnotic Analgesia Using a Multiplexed Precision Medicine Platform

Conditions
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Pain, Postoperative, Genetic Predisposition

Intervention / Treatment
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* Device: Giant magnetoresistive sensor (GMR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior enrollment in one of 3 specific hypnosis trials Enrollment is by invitation only Exclusion Criteria: Participants in the prior trials who declined to be contacted for future research.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with HIP previously measured<br>This cohort of patients will have their genetics analyzed and compared to their HIP scores. | Device: Giant magnetoresistive sensor (GMR)<br>* Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples.<br>|
| Participants without HIP measured<br>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. | Device: Giant magnetoresistive sensor (GMR)<br>* Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent concordance of rapid genotyping of SNPs with giant magnetoresistive sensors vs. genotyping using pyrosequencing | 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 | Through study completion, average of 2 years | 
| Determine which COMT SNP haplotypes associate with high/medium/low hypnotizability measured by the Hypnotic Induction Profile score. |  | Through study completion, average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Determine if there is a relationship between COMT diplotypes/haplotypes and pain or opioid use in a subgroup of patients who underwent hypnosis prior to knee replacement surgery vs. patients in the control group who were not hypnotized, during their inpatient admission postoperatively | Through study completion, average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis, Biosensing, technique, Pain, psychology, Analgesia,psychology, Hypnotizability, Giant Magnetoresistive Sensors