NCT06639438 Sensory Outcomes in Active Substance Users
| NCT ID | NCT06639438 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Post Operative Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-02 |
| Primary Completion | 2026-12 |
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 40 participants in total. It began in 2025-02-02 with a primary completion date of 2026-12.
⚠ 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
The incidence and severity of postoperative pain after spine surgery are notably high, often requiring intensive management and potentially affecting the patient's recovery, satisfaction, and long-term outcomes. Post-operative pain is particularly difficult to manage in patients with substance use disorder likely due to a combination of withdrawal symptoms and molecular changes in the pain matrix. Opiates are the leading cause of overdose related fatalities, and carry a significant burden of substance related morbidity and mortality. As over 80% of patients undergoing low-risk surgery receive opioid prescriptions, the investigators aim to identify unique molecular characteristics of pain within current and previous opioid users, which have been understudied in this context. This study also seeks to understand the molecular mechanisms underlying worsened postoperative pain in patients with opioid use disorder (OUD). Flow cytometry analysis of human serum will be done, which will assess circulating immune cells that can contribute to exacerbated surgery site inflammation. Spatial profiling of gene expression will be done in the dermis using Visium slide sequencing, focusing on the interplay between nerve endings, resident immune cells, and supporting dermal cells, all of which collectively contribute to the sensation pain. Both the visual pain rating scale and McGill Pain Questionnaire will be used to comprehensively quantify pain outcomes during the participant's postoperative recovery stay after surgery in an effort to better understand postoperative pain management with biomarkers of worsened postoperative pain.
Eligibility 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.
Contact & Investigator
Ala Nozari, MD PhD
PRINCIPAL INVESTIGATOR
Boston Medical Center, Anesthesiology
Frequently Asked Questions
Who can join the NCT06639438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06639438 currently recruiting?
Yes, NCT06639438 is actively recruiting participants. Contact the research team at ala.nozari@bmc.org for enrollment information.
Where is the NCT06639438 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06639438 clinical trial?
NCT06639438 is sponsored by Boston Medical Center. The principal investigator is Ala Nozari, MD PhD at Boston Medical Center, Anesthesiology. The trial plans to enroll 40 participants.