RecruitingPhase 2Phase 3NCT05459402

Divided or Single Exposure (DOSE) Study

Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment

Sponsor

University of Maryland, Baltimore

Enrollment

150 participants

Start Date

Feb 21, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Opioid-use Disorder Methadone

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria6

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 Criteria8

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)