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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06288256
Status
Recruiting

Conditions

  • Elective Spine Surgery
  • Lumbar Spine Pathology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    No Intervention

Study Details

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.

Key Dates

First listed
Mar 1, 2024
Start date
Mar 27, 2023
Status verified
Oct 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Adults Undergoing Spine Surgery
    Adults Undergoing Spine Surgery on opiods

Primary Outcome Measure

Current Opioid Misuse Measure (COMM) Score [ Time Frame: Up to 12 months post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Spine CenterNew YorkNew York10029-

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