Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months

NCT05693675 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HSC-MS-22-0912
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.

Conditions

Spine Surgery

Keywords

opioids

Outcome Measures

Primary Outcomes (4)

• Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described

  Day of discharge (about 6 days after surgery)

• Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs)

  postop days 1 and 5

• Feasibility of study design as assessed by the number of participants for which safety was able to be assessed (respiratory events)

  ability to evaluate adverse respiratory events

  Day of discharge (about 6 days after surgery)

• Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months

  3 months after surgery

Secondary Outcomes (10)

• Number of participants for which opioid usage was able to be collected

  Day of discharge (about 6 days after surgery)

• Safety as assessed by the number of patients developing respiratory depression

  by fifth day of hospital stay

• Safety as assessed by the number of patients developing clinically significant corrected QT interval(QTc )prolongation

  by fifth day of hospital stay

• Safety as assessed by the number of participants with hallucinations

  by fifth day of hospital stay

• Safety as assessed by the number of participants with dizziness

  by fifth day of hospital stay

Study Arms (2)

Postoperative methadone

EXPERIMENTAL

Drug: Postoperative methadone; Drug: Rescue Analgesia

Postoperative placebo

PLACEBO COMPARATOR

Drug: Postoperative placebo; Drug: Rescue Analgesia

Interventions

Postoperative methadone DRUG

Participants will receive intraoperative methadone (0.2 mg/kg ideal body weight intravenously but not exceeding 20mg) followed by oral/IV methadone postoperatively according to the following scheme: A) Opioid naïve patients will receive 5mg twice daily dosage of methadone on postoperative days 1 and 2 followed by 5 mg daily on postoperative days 3, 4, and 5. B) Patients taking opioids preoperatively will continue to receive their regular opioids and additionally receive 5 mg twice a day of methadone on postoperative days 1 and 2, followed by 5 mg per day on days 3, 4 and 5.

Postoperative methadone

Postoperative placebo DRUG

Participants will receive intraoperative methadone intravenously 0.2mg/kg followed by oral placebo postoperatively according to the following scheme: Opioid naïve patients and patients taking opioids preoperatively will receive placebo tablets twice daily on day 1 and day 2 and once daily day 3, 4 and 5. Patients taking preoperative opioids will be able to return to their baseline opioids immediately after surgery.

Postoperative placebo

Rescue Analgesia DRUG

PACU analgesia for both groups will be the usual care regime of fentanyl or hydromorphone bolus as prescribed by the physician anesthesiologist doing the case. All patients receive IV intravenous patient-controlled analgesia and rescue opioids which is usual care for postoperative pain.

Postoperative methadone; Postoperative placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries

You may not qualify if:

• BMI greater than 40

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Shobana Rajan, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: October 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)