Understanding pain in patients with opioid use disorder after spine surgery
Official title: Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use
Run by Boston Medical Center · NCT06639438 · Data updated 2026-11-12
This study looks at how pain after spine surgery is different for people with opioid use disorder compared to those without, to help find better ways to manage their pain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | February 2, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT06639438 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with current opioid use disorder requiring high doses of opioids for chronic pain and those without a history of opioid use undergoing elective spine surgery.
✕Probably not a fit
Patients with contraindications for elective surgery or those with no history of opioid use may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the differences in postoperative pain experiences between patients with opioid use disorder (OUD) and those without after elective spine surgery. It will utilize pain questionnaires, flow cytometry, and spatial transcriptomics to assess pain reception, immune signatures, and molecular characteristics associated with pain signaling. By examining these factors, the study seeks to uncover the underlying mechanisms that contribute to heightened postoperative pain in individuals with a history of opioid use. The findings could provide insights into tailored pain management strategies for this vulnerable population.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients with opioid use disorder, enhancing their recovery and overall satisfaction after surgery.
How similar studies have gone: While studies have explored pain management in opioid users, this specific approach focusing on molecular characteristics in the postoperative setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Opioid user cohorts: * Individuals with current OUD as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Individuals requiring ≥20 mg of MME/day medication to manage a chronic pain problem. * Patients scheduled to undergo elective surgery * Able to provide informed consent Control Group Cohorts: * Individuals who are not taking high dose opioids (≤20 MME/day) nor illicit substances and have no history of opioid use disorder * Individuals with reported chronic pain not yet taking medication for their pain * Patients scheduled to undergo elective surgery * Able to provide informed consent Exclusion Criteria: Substance User Cohort: * Patients with contraindications for elective surgery * Individuals with no history of opioid use Control Group Cohort: * Individuals with a history of opioid use \>20 MME/day or illicit substance use * Patients with contraindications for elective surgery.
Where it's running
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Boston Medical Center/Boston University Medical Campus
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Ala Nozari, MD PhD — Boston Medical Center, Anesthesiology
- Study coordinator: Ala Nozari, MD PhD
- Email: ala.nozari@bmc.org
- Phone: 617-638-6950
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.