Actively Recruiting
Sensory Outcomes in Active Substance Users
Led by Boston Medical Center · Updated on 2026-02-10
40
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sensory Outcomes in Active Substance Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with current opioid use disorder as defined by DSM-5
- Individuals requiring 20 mg or more of morphine milligram equivalents (MME) per day to manage chronic pain
- Patients scheduled to undergo elective surgery
- Able to provide informed consent
- Individuals not taking high dose opioids (20 MME/day or less) nor illicit substances and with 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
You will not qualify if you...
- Patients with contraindications for elective surgery
- Individuals with no history of opioid use (for substance user cohort)
- Individuals with a history of opioid use above 20 MME/day or illicit substance use (for control group cohort)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Boston Medical Center/Boston University Medical Campus
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
A
Ala Nozari, MD PhD
CONTACT
X
Xuan He, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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