COMT Activity and Hypnotizability

• Conditions: Genetic Predisposition; Pain, Postoperative
• Interventions: Device: Giant magnetoresistive sensor (GMR)

• Registration Number: NCT04624880
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Study Start: 2021-01-13
• Primary Completion: 2021-07-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with HIP previously measured	Giant magnetoresistive sensor (GMR)	This cohort of patients will have their genetics analyzed and compared to their HIP scores.
Participants without HIP measured	Giant magnetoresistive sensor (GMR)	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.

Primary Outcome Measures

Name	Time	Method
Percent concordance of rapid genotyping of SNPs with giant magnetoresistive sensors vs. genotyping using pyrosequencing	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.	Through study completion, average of 2 years

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Stanford University/Stanford Healthcare; 🇺🇸 Palo Alto, California, United States