COMT Activity and Hypnotizability

NCT04624880 | Completed FDA Device

• 1 other identifier: 58341
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Genetic Predisposition

Keywords

Hypnosis; Biosensing, technique; Pain, psychology; Analgesia,psychology; Hypnotizability; Giant Magnetoresistive Sensors

Outcome Measures

Primary Outcomes (2)

• 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 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.

  Through study completion, average of 2 years

Study Arms (2)

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)

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)

Interventions

Giant magnetoresistive sensor (GMR) DEVICE

Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples.

Participants with HIP previously measured; Participants without HIP measured

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Prior enrollment in one of 3 specific hypnosis trials
• Enrollment is by invitation only

You may not qualify if:

• Participants in the prior trials who declined to be contacted for future research.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University/Stanford Healthcare

Palo Alto, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples for DNA analysis

MeSH Terms

Conditions

Pain, Postoperative; Genetic Predisposition to Disease; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Disease Susceptibility; Disease Attributes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Shan Wang, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• David Spiegel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 12, 2020
• Study Start: January 13, 2021
• Primary Completion: July 4, 2021
• Study Completion: July 13, 2021
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)