Status:

RECRUITING

Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study

Lead Sponsor:

The Cleveland Clinic

Conditions:

Post Operative Pain

Spinal Surgery

Eligibility:

All Genders

18-72 years

Phase:

PHASE4

Brief Summary

The investigators propose a randomized, triple-blinded (patients, investigators, outcomes assessors), placebo-controlled pilot feasibility trial (Methadone to End Narcotic Dependence, MEND trial) to a...

Detailed Description

The Centers for Disease Control and Prevention reports a nearly 10-fold increase in the number of deaths from all types of drug overdose over the past 20 years, including 82,000 deaths that occurred i...

Eligibility Criteria

Inclusion

  • Adult ≥ 18 years of age
  • Scheduled for multilevel lumbar and/or thoracic spine fusion (primary or revision)

Exclusion

  • \<18 or \>72 Years of age
  • Body Mass Index \>40
  • Known allergy to methadone
  • Pregnant females
  • Non-English-speaking patients

Key Trial Info

Start Date :

November 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2028

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT07222072

Start Date

November 15 2025

End Date

October 1 2028

Last Update

December 17 2025

Active Locations (1)

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Cleveland Clinic

Cleveland, Ohio, United States, 44195