Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery
Recruiting now
Conditions studied: Lumbar Spine Pathology, Elective Spine Surgery
In brief
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 facts
- Study ID
- NCT06288256
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 60
- Starts
- 2023-03-27
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2024-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Mount Sinai Spine Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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