Recruiting

Methadone

Sponsor:

The Cleveland Clinic

Code:

NCT07222072

Conditions

Post Operative Pain

Spinal Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Methadone

Placebo

Study Details

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 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.

Conditions

Post Operative Pain

Spinal Surgery

Study ID

NCT07222072

Start date

Nov 15, 2025

Status verified date

Dec, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Methadone

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

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.

Primary outcome measure

  • Feasibility and Acceptability-Participant Willingness/Recruitment [ Time Frame: 7 days ]
  • Feasibility and Acceptability-Provider Engagement [ Time Frame: 7 days ]
  • Feasibility and Execution-Protocol Compliance and Execution [ Time Frame: 7 days ]
  • Acceptability and Execution-Baseline Stratification Data [ Time Frame: 18 months ]
  • Feasibility and Execution-Follow-Up Completion [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Stephanie Stoianoff, MBA

12164440231stoians@ccf.org

Sandra Durbin, CLPN, CCRP

216-269-4073durbins@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Stephanie Stoianoff, MBA

216-444-0231stoians@ccf.org

Sandra Durbin, CLPN, CCRP

durbins@ccf.org

Principal Investigator:

Shobana Rajan, M

More Information

Sponsor

The Cleveland Clinic

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Methadone
  • non-opioid
  • spinal surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-12-17.