Sensory Outcomes in Active Substance Users

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT06639438
Status
Recruiting
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Conditions

  • Opioid Use, Unspecified
  • Post Operative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Feb 2, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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

Primary Outcome Measure

Specific gene expressed [ Time Frame: The date of scheduled surgery assessed through the study completion, about two years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical Center/Boston University Medical CampusBostonMassachusetts02118
Ala Nozari, MD PhD
[email protected]
617-638-6950
Xuan A He, PhD
[email protected]
617-638-6950
Venetia Zachariou, PhD (PRINCIPAL_INVESTIGATOR)
Ala Nozari, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Medical Center/Boston University Medical Campus· Boston, MA

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