Methadone to reduce long-term opioid use after major spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, triple-blinded, placebo-controlled pilot feasibility trial comparing postoperative oral methadone to placebo in patients undergoing multilevel lumbar or thoracic spine fusion. The trial will enroll adult English-speaking patients at a single center and collect data on feasibility, safety, and preliminary opioid use outcomes at three months. Investigators will use the pilot data to plan a larger definitive trial testing methadone's opioid-sparing effects after spine surgery. Standard exclusion criteria include extreme obesity (BMI >40), pregnancy, known methadone allergy, and non-English speakers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Shobana Rajan, MD — The Cleveland Clinic
• Study coordinator: Stephanie Stoianoff, MBA
• Email: stoians@ccf.org
• Phone: 12164440231

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.