Divided or Single Exposure (DOSE) Study
RecruitingPhase 2, Phase 3NCT05459402
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment
- Conditions
- Opioid Use Disorder
- Chronic Pain
- Methadone
- Interventions
- Drug: Methadone (100% dose)
- Drug: Methadone (50% dose)
- Sponsor
- University of Maryland, Baltimore
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2023-02-21
- Primary completion
- 2027-06-01
- Sex
- All
- Age range
- from 18 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05459402