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 — OTHERNo 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 SurgeryAdults Undergoing Spine Surgery on opiods
Primary Outcome Measure
Current Opioid Misuse Measure (COMM) Score [ Time Frame: Up to 12 months post-operatively ]
Central Contacts
- Chinwe Nwaneshiudu, MD PhD212-241-4203
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mount Sinai Spine Center | New York | New York | 10029 | - |