Clinical Trial

Older Adults, Methadone, and Cognitive Function

Completed
View on ClinicalTrials.gov →
Summary
The increasing prevalence of opioid use disorder (OUD) among older adults, coupled with high overdose rates and cognitive impairments associated with opioid use, highlights a critical gap in addiction treatment. Cognitive impairments can persist despite treatment and negatively impact recovery outcomes, yet cognitive screening and interventions are rarely integrated into OUD care. This study aims to evaluate the feasibility of remotely delivered, smartphone-based cognitive assessments (administered through NeuroUX web-based software) for older adults (55+) in methadone treatment. The tasks have been "gamified" to make them engaging and brief, which could be appealing to patients. They will complete the tasks for 15 days using the phone provided or their own phone. During days 6-15 of testing, tasks will become incrementally more difficult based on participant performance to assess the feasibility of cognitive training. Cognitive training uses engaging games or tasks to strengthen thinking skills like memory and focus, much like physical exercise strengthens the body. Adherence, acceptability, and usability of the tasks will be assessed. Secondary analyses will explore relationships between task performance and participant characteristics (e.g., baseline cognitive functioning, methadone dose, timing of methadone dose). Findings from this pilot study will provide foundational data for a future grant application to develop and test digital cognitive assessment and training interventions tailored to older adults in addiction treatment. By addressing a critical yet understudied aspect of OUD care this research has the potential to enhance treatment engagement, improve clinical outcomes, and support long-term recovery in the growing older population.
Protocol Amendment History 5 changes
critical Trial completed 2026-07-30
notable Enrollment reduced: 30 -> 24 participants 2026-07-30
critical Trial status changed: Enrolling by Invitation → Recruiting 2026-06-04
notable Primary completion moved earlier: 2026-10-31 -> 2026-07-01 2026-06-04
minor Completion moved earlier: 2027-01-15 -> 2026-07-01 2026-06-04
Trial Details
NCT Number NCT07153029
Lead Sponsor University of Maryland, Baltimore
Collaborators: National Institute on Aging (NIA)
Conditions Opioid Use Disorder, Cognitive Ability General
Enrollment 24 participants
Start Date 2024-12-03
Primary Completion 2026-07-08 (estimated)
Study Completion 2026-07-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-29