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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07222072
Phase
PHASE4
Status
Recruiting
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Conditions

  • Post Operative Pain
  • Spinal Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 72 Years
Healthy Volunteers
Accepted

Interventions

  • Methadone — DRUG
    Patients randomized to receive (blinded) methadone: 5 mg twice daily on postoperative (post-op) days 1 and 2 followed by 5 mg daily on postop days 3, 4, and 5.
  • Placebo — DRUG
    Patients randomized to receive (blinded) placebo will receive placebo twice daily on day 1 and day 2 and once daily on day 3, 4 and 5. Patients taking preoperative opioids will return to baseline opioid schedule after surgery.

Study Details

The investigators propose a randomized, triple-blinded (patients, investigators, outcomes assessors), placebo-controlled pilot feasibility trial (Methadone to End Narcotic Dependence, MEND trial) to assess the feasibility and safety of postoperative oral methadone in patients undergoing spine surgery and collect preliminary data to inform a larger clinical trial that will test the opioid-sparing effects of methadone at 3 months after spine surgery.

Key Dates

Start date
Nov 15, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Methadone Group
    Patients randomized to receive post operative methadone
  • Placebo Comparator: Patients randomized to receive (blinded) placebo
    Patients will receive post operative placebo

Primary Outcome Measure

Feasibility and Acceptability-Participant Willingness/Recruitment [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Stephanie Stoianoff, MBA
[email protected]
216-444-0231
Sandra Durbin, CLPN, CCRP
[email protected]
Shobana Rajan, M (PRINCIPAL_INVESTIGATOR)

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