Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment
University of Maryland, Baltimore
Summary
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.
Description
This study follows a successfully completed project (NCT03254043) to now pursue the investigators overarching goal of optimizing methadone dosing as a method for managing comorbid chronic pain and opioid use disorder (OUD) among persons receiving methadone for the treatment of OUD. Up to 62% of persons maintained on methadone for OUD experience clinically significant pain, versus 31% in the general population. Pain in methadone-maintained persons (MMP) is associated with poor OUD treatment outcomes and severe distress. No effective treatment for comorbid pain and OUD currently exists; though p…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 unstab…
Interventions
- DrugMethadone (100% dose)
Methadone for the treatment of opioid use disorder
- DrugMethadone (50% dose)
Methadone for the treatment of opioid use disorder
Location
- Addiction Treatment Services (ATS)Baltimore, Maryland