RECRUITING

Sensory Outcomes in Active Substance Users

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Individuals With Chronic Pain or Persistent Opioid Use

Quick Facts

Study Start:2025-02-02
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06639438

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals with current OUD as defined by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  2. * Individuals requiring ≥20 mg of MME/day medication to manage a chronic pain problem.
  3. * Patients scheduled to undergo elective surgery
  4. * Able to provide informed consent
  5. * Individuals who are not taking high dose opioids (≤20 MME/day) nor illicit substances and have no history of opioid use disorder
  6. * Individuals with reported chronic pain not yet taking medication for their pain
  7. * Patients scheduled to undergo elective surgery
  8. * Able to provide informed consent
  1. * Patients with contraindications for elective surgery
  2. * Individuals with no history of opioid use
  3. * Individuals with a history of opioid use \>20 MME/day or illicit substance use
  4. * Patients with contraindications for elective surgery.

Contacts and Locations

Study Contact

Ala Nozari, MD PhD
CONTACT
617-638-6950
ala.nozari@bmc.org
Xuan He, PhD
CONTACT
617-638-6950
xuan.he@bmc.org

Principal Investigator

Ala Nozari, MD PhD
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Anesthesiology

Study Locations (Sites)

Boston Medical Center/Boston University Medical Campus
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Ala Nozari, MD PhD, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Anesthesiology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-02
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02-02
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Opioid use disorder (OUD)
  • Gene expression
  • Visium slide sequencing
  • Inflammatory profile
  • Sensation pain
  • Flow cytometry

Additional Relevant MeSH Terms

  • Post Operative Pain
  • Opioid Use, Unspecified