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Divided or Single Exposure (DOSE) Study

RecruitingPhase 2/3

Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment

Who can join

Ages 18 to 100 · All sexes

Full eligibility 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)

About the study

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.

What is being tested

Sponsor: University of Maryland, Baltimore · Participants: 150 · Started: Feb 21, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05459402

Locations in the U.S.

MarylandAddiction Treatment Services (ATS), Baltimore

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.