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

NCT06288256 | Recruiting

• 1 other identifier: STUDY-22-01390
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spine Pathology; Elective Spine Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Numerical Rating Scale (NRS) Score

  Up to 12 months post-operatively

Study Arms (1)

Adults Undergoing Spine Surgery

Adults Undergoing Spine Surgery on opiods

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Adults Undergoing Spine Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

undergoing elective spine surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Spine Center

New York, New York, 10029, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

• Chinwe Nwaneshiudu

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chinwe Nwaneshiudu, MD PhD

CONTACT

212-241-4203; chinwe.nwaneshiudu@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: March 27, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Immediately following publication. No end date.
• 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).

Locations

US (1)