Recruiting

Oxycodone & Methadone

Sponsor:

OpalGenix, Inc

Code:

NCT05452694

Conditions

Lumbar Spine Stenosis

Lumbar Spine Degeneration

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone, in adults following lumbar spinal fusion and decompression surgery. Genetic signature and combinatorial pharmacogenetic approaches perform better than single-gene associations. This innovative translational research will for the first time evaluate simultaneously the effects of multiple genes and interactions on oxycodone and methadone's pharmacokinetics and optimal clinical dosing and on its safety and efficacy in the highly vulnerable pediatric population. This research's multigenetic signature findings can be easily extrapolated to adults undergoing surgery or using oxycodone and/or methadone for chronic and cancer pain and in identifying opioid abusers at risk of severe respiratory depression and death.

When methadone is given in addition to oxycodone for inpatient pectus excavatum repair and idiopathic scoliosis spinal fusions according to new departmental protocols, methadone pharmacokinetics and pharmacodynamics will also be evaluated.

Conditions

Lumbar Spine Stenosis

Lumbar Spine Degeneration

Study ID

NCT05452694

Start date

Nov 1, 2022

Status verified date

Apr, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 18, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • >18 years of age
  • American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3
  • Undergoing lumbar spine surgeries (lumbar spine decompression, multilevel posterior spine fusion, internal fixation or a combination) for degenerative lumbar spine and lumbar spinal stenosis and requiring opioids for perioperative pain management

Exclusion Criteria:

  • Children (<18 years of age)
  • Pregnant women
  • American Society of Anesthesiologists (ASA) Physical Status 4 or above
  • Non-English speaking
  • Outpatient surgery
  • Concomitant additional surgical procedures
  • Significant liver or kidney dysfunction
  • Significant cardiorespiratory compromise
  • Patients with polysubstance use (e.g., cocaine, marijuana, amphetamine, etc.)

Study Design

Enrollment

235 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Opioid-related Post-operative nausea and vomiting (PONV) [ Time Frame: Post-operative up to 12 months ]
  • Opioid-related sedation [ Time Frame: Post-operative up to 12 months ]
  • Opioid-related respiratory depression (RD) [ Time Frame: Post-operative up to 12 months ]

Central Contacts and Locations

Central contacts

Locations

UPMC Montefiore Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Kathirvel Subramaniam, MD

subramaniamk@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Kathirvel Subramaniam, MD, MPH

subramaniamk@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

UPMC Pain Medicine at Centre Commons

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Kathirvel Subramaniam, MD

subramaniamk@upmc.edu

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

More Information

Sponsor

OpalGenix, Inc

Last update posted

May 1, 2025

Last verified

Apr, 2025

Keywords

  • Pain Management
  • Lumbar Spine Stenosis
  • Degenerative Lumbar Spine
  • Opioid Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OpalGenix, Inc on 2025-05-01.