Clinical trial NCT04624880: COMT Activity and Hypnotizability
Official title: COMT Activity as a Biomarker for Hypnotizability and Hypnotic Analgesia Using a Multiplexed Precision Medicine Platform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Genetic Predisposition
Keywords: Hypnosis
Biosensing, technique
Pain, psychology
Analgesia,psychology
Hypnotizability
Giant Magnetoresistive Sensors
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent concordance of rapid genotyping of SNPs with giant magnetoresistive sensors vs. genotyping using pyrosequencing
timeFrame: Through study completion, average of 2 years
measure: Determine which COMT SNP haplotypes associate with high/medium/low hypnotizability measured by the Hypnotic Induction Profile score.
timeFrame: Through study completion, average of 2 years
Secondary outcomes:
measure: 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.
timeFrame: Through study completion, average of 2 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University/Stanford Healthcare
state: California
Study officials:
affiliation: Stanford University
name: Shan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: David Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References: