A Phase 2/3 interventional study of Methadone (100% dose) and Methadone (50% dose) in Opioid Use Disorder, Chronic Pain and Methadone, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by University of Maryland, Baltimore · Phase 2/3, Interventional, and Treatment
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.
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 preclinical and human data suggest divided methadone dosing may be a more optimal strategy for managing pain than once daily dosing, this has never been empirically examined. This study will evaluate an intervention for comorbid chronic pain among MMP using a Phase II double-blind, randomized, placebo-controlled comparison of treatment as usual (TAU) versus split daily methadone dosing for 12-weeks. Methadone will be remotely managed via an electronic pillbox. Outcomes will include weekly assessments of pain and OUD outcomes, ecological momentary assessment of pain before and after dosing, and point-prevalence measures of laboratory-induced pain to explore mechanism of effects. If effective, this approach could transform the care of MMP with pain because it would be feasible to implement within the operational structure of a methadone clinic and would impose low provider burden. Results could provide a high magnitude treatment for the substantial number of MMP who experience daily pain with no reliable form of treatment.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 150 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in treatment as usual group will receive 100% active methadone in AM + placebo in PM.
Drug: Methadone (100% dose)
Participants in split dosing group will receive 50% active methadone + placebo twice daily.
Drug: Methadone (50% dose)
Methadone for the treatment of opioid use disorder
Methadone for the treatment of opioid use disorder
Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale
Using the Brief Pain Inventory rating of "Worst Pain" in the past 24 hours, rated on a scale of 1-10, collected once weekly during weeks 1 through 12 of the intervention.
Time frame: Week 1 up to week 12
Change in Pain Tolerance Latency
Time in seconds (0-300) to removal of hand from cold pressor measure of laboratory-induced pain, collected point-prevalence during weeks 1, 6, and 12 of the intervention.
Time frame: Weeks 1, 6, and 12
Change in Pain Interference- past 7 days as assessed by Pain-related Disability Scale Total Score
Past 7 day Pain-related Disability Scale Total Score (range 0-70), collected once weekly during weeks 1 through 12 of the intervention.
Time frame: Week 1 up to 12
Change in Opioid Withdrawal Severity- past 24 hours as assessed by the Subjective Opioid Withdrawal Scale
Past 24 hour total score (range 0-64) for the Subjective Opioid Withdrawal Scale (SOWS), collected once weekly during weeks 1 through 12 of the intervention.
Time frame: Week 1 up to 12
Plan to share: No
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University of Maryland, Baltimore