Sensory Outcomes in Active Substance Users
Launched by BOSTON MEDICAL CENTER · Oct 10, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the challenges of managing postoperative pain in patients who have a history of using opioids, particularly those with opioid use disorder (OUD). After spine surgery, many patients experience significant pain, which can be even harder to control for those who have used opioids. The researchers aim to understand the biological differences in pain responses between patients with OUD and those who do not use opioids. They will analyze blood samples and conduct tests on skin tissue to explore how immune cells and nerve endings interact and contribute to pain after surgery.
To participate in this study, individuals aged 65 and older who are scheduled for elective surgery may be eligible if they either have a current opioid use disorder and take a certain amount of opioids daily, or are not using opioids or illicit substances and have chronic pain but are not on medication. Participants will be asked to provide informed consent and will be monitored for their pain levels during their recovery. This research could help improve pain management strategies for patients with different histories of opioid use, ultimately enhancing their recovery experience.
Gender
ALL
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.
About Boston Medical Center
Boston Medical Center (BMC) is a leading academic medical center located in Boston, Massachusetts, dedicated to providing high-quality, compassionate care to diverse populations. As a prominent clinical trial sponsor, BMC conducts innovative research aimed at advancing medical knowledge and improving patient outcomes across a wide range of specialties. With a commitment to health equity and access to care, BMC collaborates with various stakeholders, including academic institutions and industry partners, to facilitate groundbreaking studies and translate findings into effective treatments. Its robust infrastructure and experienced research teams ensure adherence to the highest ethical standards and regulatory compliance in all clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Patients applied
Trial Officials
Ala Nozari, MD PhD
Principal Investigator
Boston Medical Center, Anesthesiology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported