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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spine Pathology; Elective Spine Surgery
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Chinwe Nwaneshiudu, MD PhD; Phone Number: 212-241-4203; Email: chinwe.nwaneshiudu@mountsinai.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

undergoing elective spine surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults Undergoing Spine Surgery; Adults Undergoing Spine Surgery on opiods	Other: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Current Opioid Misuse Measure (COMM) Score	The Current Opioid Misuse Measure (COMM) is a 17-item self-report measure with total scores ranging from 0 to 68 that is used to identify risk of opioid misuse among chronic pain patients, with higher scores indicating higher risk of opioid misuse.	Up to 12 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) Score	The Numerical Rating Scale (NRS) for pain intensity is an 11-point scale ranging from 0 to 10 that is used to measure a patient's self-reported pain intensity, with higher scores indicating more severe pain.	Up to 12 months post-operatively

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Chinwe Nwaneshiudu, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: STUDY-22-01390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

For individual participant data meta-analysis.

Proposals should be directed to chinwe.nwaneshiudu@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (TBD).

• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No