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Methadone Dosing for Pain and Opioid Use Disorder

This study, called DOSE, is looking at how different ways of taking methadone might help people who have both chronic pain and opioid use disorder (OUD). Researchers want to see if taking your methadone dose once a day or splitting it into two doses (once in the morning and once later) works better for managing pain. You might be able to join if you are 18 or older, have been taking methadone for OUD for over 90 days at a stable dose, and experience pain. The main goal is to see how your worst pain rating changes over 12 weeks. The current status of this study is unclear.

Study design
This is a Phase II, double-blind (meaning neither you nor your doctors will know which treatment you're getting), randomized (like flipping a coin to decide your group) study comparing usual care to split methadone dosing. It plans to include up to 150 participants.
What's involved
You would participate in weekly assessments of pain and OUD outcomes for 12 weeks. You would also have ecological momentary assessments of pain before and after dosing, and laboratory-induced pain measurements.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be assessed weekly for up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05459402

Divided or Single Exposure (DOSE) Study

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~150 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:Methadone (100% dose)Methadone (50% dose)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale
Measured over Week 1 up to week 12

Conditions

Opioid Use Disorder
Chronic Pain
Methadone

Explore related trials

Chronic PainOpioid Use Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Kelly E Dunn, PhD, M.B.A. · PRINCIPAL_INVESTIGATOR · University of Maryland
  • Denis Antoine, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Kelly E Dunn, PhD, M.B.A.
[email protected]
802-922-1682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scaleWeek 1 up to week 12

    Using the Brief Pain Inventory rating of "Worst Pain" in the past 24 hours, rated on a scale of 1-10, collected once weekly during weeks 1 through 12 of the intervention.