NCT06288256 Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery
| NCT ID | NCT06288256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Lumbar Spine Pathology |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-03-27 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Chinwe Nwaneshiudu
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06288256 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Spine Pathology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06288256 currently recruiting?
Yes, NCT06288256 is actively recruiting participants. Contact the research team at chinwe.nwaneshiudu@mountsinai.org for enrollment information.
Where is the NCT06288256 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06288256 clinical trial?
NCT06288256 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Chinwe Nwaneshiudu at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 60 participants.