Methadone to reduce long-term opioid use after major spine surgery
Methadone to Reduce Chronic Opioid Use After Major Spine Surgery: The MEND Pilot Feasibility Study
This pilot trial will test whether a short course of postoperative oral methadone can help adults having multilevel lumbar or thoracic spine fusion use fewer opioids three months after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 72 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07222072 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: English-speaking adults aged 18–72 scheduled for multilevel lumbar or thoracic spine fusion with BMI ≤40 who are not pregnant and have no known methadone allergy are ideal candidates.
Not a fit: Patients who are pregnant, have BMI >40, a known methadone allergy, or who do not speak English are excluded and may not receive benefit from this trial.
Why it matters
Potential benefit: If successful, the approach could reduce the risk of prolonged opioid use and its harms after spine surgery.
How similar studies have performed: Short-term intraoperative or postoperative methadone has shown opioid-sparing effects in other surgical settings, but its effect on three-month opioid use after spine surgery has not been established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.