Sensory Outcomes in Active Substance Users
Key facts
- Who runs it
- Boston Medical Center
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 2 Feb 2025
- Expected to end
- Dec 2026
- Type of study
- Observational, 4 groups
- Record updated
- 10 February 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients with contraindications for elective surgery
- 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
- Substance User Cohort:
Where in United States
- Boston Medical Center/Boston University Medical CampusBoston, United StatesContact: Ala Nozari, MD PhDTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 4 groups in the trial
- Group 1- Patients with Opioid Use Disorder (OUD)
Participants in this group will be diagnosed with OUD, defined by cognitive, behavioral, and physiological symptoms indicating using opioids despite significant opioid-related problems.
- Group 2- Patients who are engaged in long-term opioid therapy (LTOT) for chronic pain
Participants in this group will be engaged in long-term opioid therapy (LTOT) for chronic pain management under medical supervision, without exhibiting the problematic behaviors or experiencing the significant impairment or distress outlined in the OUD criteria.
- Group 3- Patients with chronic pain but no (or minimal) opioid use
Participants in this group will have chronic pain but no (or minimal) opioid use where chronic pain is defined as pain that lasts more than three months or beyond the expected period of healing but opioid use is \< 20MME with \<3 weeks of duration.
- Group 4- Patients without chronic pain
Participants in this group will not suffer from chronic pain but choose to undergo spine surgery due to structural abnormalities or conditions that could potentially lead to pain, neurological issues, or other significant health problems
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use
- Record updated
- 10 February 2026