RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-27
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06288256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age over 18
  2. * With diagnoses of lumbar, cervical or thoracic spine pathology, scheduled to undergo elective spine surgery with or without instrumentation
  1. * Severe psychiatric condition interfering with study participation Any major cardiac, pulmonary, renal, infectious, hepatic condition that interferes with study participation
  2. * Polytrauma
  3. * Prolonged hospitalization (\>10days)
  4. * Pregnancy
  5. * Known surgery cancellation within study period

Contacts and Locations

Study Contact

Chinwe Nwaneshiudu, MD PhD
CONTACT
212-241-4203
chinwe.nwaneshiudu@mountsinai.org

Principal Investigator

Chinwe Nwaneshiudu
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Spine Center
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Chinwe Nwaneshiudu, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-27
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-03-27
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Lumbar Spine Pathology
  • Elective Spine Surgery