Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06288256 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusTerminated
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Stopped Trial terminated Sponsor's reason: PI leaving Institution Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  2. Notable Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Jun 2024 to Jul 2026
    • Start date: Mar 1, 2023 to Mar 27, 2023
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06288256
Lead Sponsor Icahn School of Medicine at Mount Sinai
Conditions
(from sponsor)
Lumbar Spine Pathology, Elective Spine Surgery
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov