Sensory Outcomes in Active Substance Users

NCT06639438 | Recruiting

• 1 other identifier: H-44193
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Opioid Use, Unspecified

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Specific gene expressed

  This outcome will be assessed by the transcriptomic profile of dermal tissue from patient excision site using the Visium system to quantify gene expression changes in the dermis. Dermis tissue, about 5mm (length) x 3mm (width) x 2 mm (depth) in size, will be extracted.

  The date of scheduled surgery assessed through the study completion, about two years

• Type and concentration of inflammatory cells present and selective biomarkers

  The inflammatory profile of whole blood such as the quantity and type of circulating immune cells, e.g. complete blood count (CBC) with differential will be assessed using flow cytometry.A blood sample, about 10mL in volume, will be obtained at the preoperative waiting area immediately after IV placement.

  The date of scheduled surgery assessed through the study completion, about two years

Secondary Outcomes (6)

• Perceived pain using a visual pain scale

  ~2 weeks before surgery; 24, 36, 48, and 72 hours post-surgery before discharge; ~2 weeks after discharge

• Perceived pain using the McGill pain scale

  ~2 weeks before surgery; 24 hours post-surgery before discharge; ~2 weeks after discharge

• Anesthesia and pain management method

  Within 1 week of the surgical visit

• Opioid burden

  Within 1 week of the surgical visit

• Post-operative recovery and complications

  Within 1 week of the surgical visit

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with elective spine procedures scheduled involving incision (including laminectomy, discectomy, foraminotomy, scoliosis correction, decompression and fusion) will be divided into four groups: two no opiod use groups and two opioid use groups. The no opioid use groups will consist of two subgroups of participants with no prior pain disorders who have received no long-term opioid prescriptions (n=10), as well as patients with chronic pain disorders who have received no long-term high dose opioid prescriptions (n=10). The opioid use group will consist of two subgroups- participants with OUD (n=10), and participants without OUD, but have been prescribed opioid medication for chronic pain disorders (n=10).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center/Boston University Medical Campus

Boston, Massachusetts, 02118, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A 10 ml blood sample will be collected for serum analysis immediately before, during, and 24 hours after the surgical procedure. During the procedure, A 5mm (length) x 3mm (width) x 2 mm (depth) tissue sample from the incision site will be collected for later spatial transcriptomic analysis.

MeSH Terms

Conditions

Pain, Postoperative; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ala Nozari, MD PhD

  Boston Medical Center, Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ala Nozari, MD PhD

CONTACT

617-638-6950; ala.nozari@bmc.org

Xuan He, PhD

CONTACT

617-638-6950; xuan.he@bmc.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: February 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)