Evaluating daily dosing methods of methadone for pain and opioid use disorder
Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment
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 |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05459402 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While similar approaches have been suggested, this specific method of evaluating split dosing of methadone for pain management has not been empirically tested before.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.