Neurocognitive and Genomic Predictors of Persistent Pain... | NCT06288256

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

NCT06288256

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Lumbar Spine Pathology
Elective Spine Surgery

Interventions

No Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2023Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Feb 23, 2024

First Submission Date that Met QC Criteria

Feb 23, 2024

First Posted Date

Mar 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2024

Last Update Posted Date

Oct 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chinwe Nwaneshiudu, Assistant Professor, Icahn School of Medicine at Mount SinaiPrincipal Investigator

Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults Undergoing Spine Surgery		Adults Undergoing Spine Surgery on opiods	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	No Intervention	Adults Undergoing Spine Surgery

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

undergoing elective spine surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chinwe Nwaneshiudu, MD PhD	Contact	212-241-4203		chinwe.nwaneshiudu@mountsinai.org

Overall Officials

Name	Affiliation	Role
Chinwe Nwaneshiudu	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Spine Center	Recruiting	New York	New York	10029	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Types

Statistical Analysis Plan (SAP)
Clinical Study Report (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).

URL

Not provided