Sensory Outcomes in Active Substance Users

NCT ID: NCT06639438

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-02
• Study Completion Date: 2026-12-31

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.

Detailed Description

The objective for this research are:

1. Assess differences in pain reception in patients with existing or previous opioid use disorder versus controls after elective spine surgery via pain questionnaires at multiple time points during the perioperative care.

2. Assess circulating immune signatures and neuropeptides associated with pain signaling before and after surgery in patients with and without OUD using flow cytometry and ELISA of patient serum.

3. Assess molecular signatures of dermal cells and nerve endings patients with and without OUD using spatial transcriptomics on epidermis- and dermis-containing tissue samples from surgical incision.

Conditions

Post Operative Pain; Opioid Use, Unspecified

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ala Nozari, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Anesthesiology

Locations

Boston Medical Center/Boston University Medical Campus

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ala Nozari, MD PhD

Role: CONTACT

ala.nozari@bmc.org

617-638-6950

Xuan He, PhD

Role: CONTACT

xuan.he@bmc.org

617-638-6950

Facility Contacts

Ala Nozari, MD PhD

Role: primary

ala.nozari@bmc.org

617-638-6950

Xuan A He, PhD

Role: backup

xuan.he@bmc.org

617-638-6950

Other Identifiers

H-44193

Identifier Type: -

Identifier Source: org_study_id