A Double-blind, Randomized, Placebo-controlled Comparison of TAU vs Split Daily Methadone Dosing for Pain Among MMP

• Status: Not yet recruiting
• Trial end date: 2028-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Methadone

Criteria

Inclusion Criteria:

• Aged 18 years of age or older

• Currently receiving methadone for treatment of OUD for >90 days and have been consuming the same dose for >30 days

• Have previously received a take-home dose of methadone as part of routine care

• Willing to comply with study schedule

• Report pain (specific definition blinded)

• Have a cellular phone or be willing to carry phone provided by the study during one phase of the study

Exclusion Criteria:

• Pregnant

• Presence of acute medical problem that requires immediate and intense medical management

• Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and/or adherence to study visits

• Plans to leave methadone treatment during the study period

• Maintained on a dose of methadone that would prevent effective splitting of doses

• Currently receiving split doses of methadone

• Currently receiving treatment for pain for which the split-dosing of methadone is judged by medical staff to be contraindicated or otherwise interfere with study conduct or integrity

• Does not meet criteria for mild-severe disability (definition blinded)