Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06288256

Conditions

Lumbar Spine Pathology

Elective Spine Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

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.

Conditions

Lumbar Spine Pathology

Elective Spine Surgery

Study ID

NCT06288256

Start date

Mar 27, 2023

Status verified date

Oct, 2024

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults Undergoing Spine Surgery

Adults Undergoing Spine Surgery on opiods

Interventions

No Intervention

No Intervention

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Spine Center

Recruiting

New York, New York, United States, 10029

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 16, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2024-10-16.