Overview

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)