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One dose or two? study aims to ease pain for people on methadone

NCT ID NCT05459402

Symptom relief Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether taking methadone once a day or twice a day works better for people who have both chronic pain and opioid use disorder. About 150 adults currently on methadone treatment will be randomly assigned to one of the two dosing schedules. Researchers will track pain levels and tolerance over 12 weeks to find the best approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome opiate dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pain Methadone Opioid-use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addiction Treatment Services (ATS)

    RECRUITING

    Baltimore, Maryland, 21224, United States

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