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Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery

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Mount Sinai Health System

Status

Enrolling

Conditions

Lumbar Spine Pathology
Elective Spine Surgery

Treatments

Other: No Intervention

Study type

Observational

Funder types

Other

Identifiers

NCT06288256
STUDY-22-01390

Details and patient eligibility

About

Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.

To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.

This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age over 18
  • With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation

Exclusion criteria

  • Severe psychiatric condition interfering with study participation Any major cardiac, pulmonary, renal, infectious, hepatic condition that interferes with study participation
  • Polytrauma
  • Prolonged hospitalization (>10days)
  • Pregnancy
  • Known surgery cancellation within study period

Trial design

60 participants in 1 patient group

Adults Undergoing Spine Surgery
Description:
Adults Undergoing Spine Surgery on opiods
Treatment:
Other: No Intervention

Trial contacts and locations

1

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Central trial contact

Chinwe Nwaneshiudu, MD PhD

Data sourced from clinicaltrials.gov

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