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

NCT ID: NCT06288256

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-27

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lumbar Spine Pathology Elective Spine Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults Undergoing Spine Surgery

Adults Undergoing Spine Surgery on opiods

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Chinwe Nwaneshiudu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chinwe Nwaneshiudu

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Spine Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chinwe Nwaneshiudu, MD PhD

Role: CONTACT

212-241-4203

Other Identifiers

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STUDY-22-01390

Identifier Type: -

Identifier Source: org_study_id

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