Evaluating daily dosing methods of methadone for pain and opioid use disorder
Official title: Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment
Run by University of Maryland, Baltimore · NCT05459402 · Data updated 2026-11-12
This study is testing whether taking methadone once or twice a day can better help people with chronic pain and opioid use disorder who are already on methadone treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | February 21, 2023 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT05459402 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been on a stable dose of methadone for opioid use disorder for at least 30 days and report experiencing pain.
✕Probably not a fit
Patients who are pregnant, have acute medical issues requiring immediate care, or are currently receiving split doses of methadone will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to determine the effectiveness of once versus twice daily dosing of methadone in managing chronic pain and opioid use disorder (OUD) among individuals already receiving methadone treatment. Following a previous successful project, the study will employ a Phase II double-blind, randomized, placebo-controlled design to compare treatment as usual with split daily dosing over a 12-week period. Participants will be monitored through weekly assessments and ecological momentary assessments to evaluate pain and OUD outcomes. The intervention will utilize an electronic pillbox for remote management of methadone dosing.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and treatment outcomes for individuals with opioid use disorder.
How similar studies have gone: While similar approaches have been suggested, this specific method of evaluating split dosing of methadone for pain management has not been empirically tested before.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Addiction Treatment Services (ATS)
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Kelly E Dunn, PhD, M.B.A. — University of Maryland
- Study coordinator: Kelly E Dunn, PhD, M.B.A.
- Email: kelly.dunn@som.umaryland.edu
- Phone: 802-922-1682
Similar studies
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Using THC and CBD to treat chronic pain and opioid cravings
This study is testing if a mix of THC and CBD can help people with chronic pain and opioid cravings feel better while they are on methadone.
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Using cannabis oil to support opioid addiction treatment
This study is trying out a balanced cannabis oil to see if it can help people with opioid addiction who are also getting treatment with methadone.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.