Divided or Single Exposure (DOSE) Study
Recruiting now · Phase 2/Phase 3
Conditions studied: Opioid Use Disorder, Chronic Pain, Methadone
In brief
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.
Key facts
- Study ID
- NCT05459402
- Run by
- University of Maryland, Baltimore
- People needed
- 150
- Starts
- 2023-02-21
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-02-03
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Addiction Treatment Services (ATS) — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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