COMT Activity and Hypnotizability

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain, Postoperative; Genetic Predisposition
• Intervention / Treatment: Device: Giant magnetoresistive sensor (GMR)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University/Stanford Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in this trial are drawn from three prior trials. One trial measured hypnotizability and collected genetic samples with permission to use for future research, 23 samples will be drawn from this cohort. The second trial measured hypnotizability in healthy volunteers, 42 participants agreed to be contacted for future studies will be invited to participate by submitting a saliva sample for DNA analysis. The third trial used hypnotic analgesia for knee replacement surgery, approximately 32 patients had hypnotizability tested and will be invited to participate for the primary analysis. Another approximately 30 patients from the control group of that trial had pain and opioid use collected postoperatively, and will be invited to provide genetic sample to be used for the secondary outcome analysis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with HIP previously measured; This cohort of patients will have their genetics analyzed and compared to their HIP scores.	Device: Giant magnetoresistive sensor (GMR); Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples.
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.	Device: Giant magnetoresistive sensor (GMR); Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Shan Wang, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2021
• Primary Completion (ACTUAL): July 4, 2021
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (ACTUAL): November 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Hypnosis; Biosensing, technique; Pain, psychology; Analgesia,psychology; Hypnotizability; Giant Magnetoresistive Sensors
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease Attributes; Pain, Postoperative; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: 58341

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes