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OpenTrials
Completed

NCT Number: NCT04624880

COMT Activity and Hypnotizability

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.

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Key information

Conditions

Pain, Postoperative Agnosia Disease Attributes Disease Susceptibility Genetic Predisposition Genetic Predisposition to Disease Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University/Stanford Healthcare

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Giant magnetoresistive sensor (GMR)

Device

Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples.

Primary outcomes

  1. Percent concordance of rapid genotyping of SNPs with giant magnetoresistive sensors vs. genotyping using pyrosequencing

    Time frame: 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

  2. Determine which COMT SNP haplotypes associate with high/medium/low hypnotizability measured by the Hypnotic Induction Profile score.

    Time frame: Through study completion, average of 2 years

Secondary outcomes

  1. 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.

    Time frame: Through study completion, average of 2 years

    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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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